ANZCTR search results

Background: Gout is increasing despite effective therapies to lower serum urate concentrations to 0.36 mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate lowering therapy (ULT) is poor, with rates of less than 50% one year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. Aims: We aim to evaluate the effectiveness of use of a personal, self-management, ‘smartphone’ application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT. Method: A prospective, cluster randomised controlled trial is conducted in primary care setting. GP practices are randomised to either intervention or control clusters with their patients allocated to the same cluster. The intervention group has access to the Healthy.me app tailored for the self-management of gout. The control group patients have access to the same app modified to remove all functions except the Gout Attack Diary. Outcome measures: Primary outcome is the proportion of patients whose serum urate concentrations are less than or equal to 0.36 mmol/L after 6 months. Secondary outcomes are proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a =30% improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed ‘drop-out’ rate 20%. Conclusion: The study is being conducted. Involvement of GPs is essential to the management of people with gout in the community and in the evaluation of usefulness of new technology in primary care.

This will be an observational study in CF patients with mild lung disease, examining the relationship between neurocognitive function and sleep parameters. Additional factors to be studied include hypoxemia, inflammatory markers, circadian rhythm and mood. CF participants will be tested at baseline, during and after lung exacerbation. Age and education matched non-CF controls will be invited to participate as well. Summary of tests to be performed at each visit: 1. Sleep study with high density EEG 2. Blood tests 3. Activity and oxygen monitoring with watches 4. Neurocognitive tests and Questionnaires.

The primary objective of the study is to investigate whether frailty increases the risk of major haemorrhage / clinically significant non-major bleed in older patients initiating an oral anticoagulant. The secondary objectives are to investigate whether frailty is a risk factor for cessation of oral anticoagulants, stroke / VTE and the association between pharmacological risk factors ability to predict the primary and secondary outcomes will be investigated in frail and non-frail participants.

This study aims to assess the safety, tolerability and pharmacokinetics of HMPL-689 in healthy adult volunteers. Who is it for? You may be eligible to join this study if you are a healthy adult aged between 18 and 45 years. Study details This study is evaluating safety of a new drug known as HMPL-689, that could be used for treatment of autoimmune diseases and B-cell mediated malignancies, in healthy adults. Participants will receive a single dose of HMPL-689 or matching placebo on Day 1 of their admission into the Phase 1 unit. The planned dose levels are: 1, 2.5, 5, 10, 20, 25 and 30 mg (about 7 cohorts of 8 subjects). In each dose cohort, 8 subjects will be randomized to receive HMPL-689 (6 subjects) or placebo (2 subjects) under fed conditions with a standard meal. For the first dose cohort (1 mg), a group of 2 subjects (1 HMPL-689 and 1 placebo) will be dosed 24 hours prior to the planned dosing of the remaining 6 subjects. Decisions regarding escalation to the next dose or termination of the study will be made jointly by the principal investigator and the sponsor based on the clinical data (safety, tolerability, available PK data and clinical laboratory values) of each dose cohort. Any dose level maybe repeated or reduced if deemed appropriate by the Principal Investigator and Sponsor’s medical expert. The estimated study participation for each participant is approximately 5 weeks. Follow up and assessments performed over these 5 weeks include: a) Collection of medical history b) Alcohol breath testing c) Regular physical exams d) ECG and vital signs measurements e) Urine sample assessments for general heath, safety and testing for drugs of addiction f) Blood sample analysis for routine measurements including clinical laboratory safety testing and screening for HIV (AIDS virus), hepatitis and tuberculosis (TB) g) Semen sample analysis h) Pharmacokinetic blood sample collections to measure the amount of study drug in your blood i) Adverse events monitored throughout the treatment period j) Use of concomitant medications reviewed throughout the study

This study is about identifying what genetic differences and dermatological characteristics (such as form and structure of moles and eye/hair colour), are associated with skin cancers and who is at greatest risk. The study is also looking at how people conduct their own skin self-examinations. Who is it for? We will be contact people via letter off the Brisbane Electoral Roll. The letter will include a Information sheet and contact details in which the letter recipient can use to make an initial appointment to participate in the study. Study details: Participants will be required to attend the Princess Alexandra Hospital, Clinical Research Facility for an appointment that will involve questionnaires, skin examination and mapping of skin naevi using 3D total body photography in their underwear. The participant will need to provide a saliva sample in order to sequence their genomic DNA. We will also ask participants to conduct a skin self-examination every 3 months for the duration of the study (3 years). Half of the participants will be randomised to receive a dermatoscope attachment for their mobile phone to use in the self examinations. We will also require participants to attend follow up visits every 6 months for the duration of the study. These visits will involve a repeat of 3D total body photography to monitor skin naevi changes. We will also ask participants to consider donating benign naevi for excision and any residual tissue from suspicious lesions recommended for excision. Tissue donated will be used for additional molecular analysis of gene products and proteins known to be involved in melanoma development and progression. This aspect of the study is optional, and will not affect eligibility for the trial.

Unintended perioperative hypothermia, defined as a core body temperature less than 36 degree celsius is not uncommon in elderly surgical patient. In the operating theatre, a combination of altered thermoregulatory mechanisms induced by anaesthesia and cooler ambient temperatures cause a decrease in core temperature.Unintended perioperative hypothermia can result in increased complications such increased surgical site infection, adverse cardiovascular events, delayed recovery from anaesthesia, increased surgical bleeding, impaired immune function, prolonged recovery room stay and hospitalization and increased costs. Different modalities of warming patients have been suggested such as forced air warmers or Bair Huggers, warming intravenous fluids, pre-warming patients from 30 minutes before surgery, warmed cotton blankets, but on many occasions, they have not been very effectively used resulting in unintended hypothermia. Elderly patients are more prone to hypothermia because of increase in frailty, comorbidities, impaired thermoregulation with age. In the current study, we aim to study the changes to the body temperature in patients undergoing hip fracture surgery through the perioperative course .

The purpose of this project is to design and pilot an advanced train-the-trainer course for Occupational Therapists, Physiotherapists and Rehab Assistants (clinicians) to strengthen their skills to coach people with neurological conditions to independently use the SMART Arm to drive their own arm recovery. A sequential mixed methods design will be utilised with a sample of 40 people with a neurological condition and 10 clinicians working at CRnQ. Phase I of the study will involve development and administration of a quantitative survey questionnaire to determine requirements for SMART Arm Advanced Training. Established SMART Arm clinical guidelines and recent findings in the scientific literature will be utilised for this purpose. The newly developed survey will be administered with participating clinicians and people with neurological conditions who have respectively delivered, or participated in, SMART Arm training at CRnQ. In order to verify and interpret survey findings, two focus groups will be conducted, one with clinicians and one with a selection of people with neurological conditions, all of whom will have participated in the survey. Focus groups will be audiotaped and transcribed verbatim and content analysis of the data undertaken. Phase II of the study will involve development and piloting of the SMART Arm Advanced Train-the Trainer Course materials and corresponding Capability Assessment Tool and will be based on Phase I outcomes. All participating clinicians will undertake the new Train-the-Trainer Course and complete the Capability Assessment Tool, with respect to their own capability. Group feedback on collated results will be provided to clinicians promptly and advice provided on areas for improvement. Three months and six months later, clinicians will complete the Capability Assessment Tool again. In addition, those individuals with a neurological condition that have participated in SMART Arm training during the period following delivery of the Advanced Training course will complete the Capability Assessment (with respect to clinicians capability) at the three month and six month time period. At each timepoint, group feedback on collated results will be provided to clinicians and advice given to address areas for improvement.

Neck pain is highly prevalent and a leading cause of disability worldwide. Manual therapies are commonly used to treat neck pain, and there is some evidence of the effectiveness of mobilisation and manipulation for neck pain. When compared with each other, mobilisation and manipulation have been shown to have similar effects. In light of the potential serious adverse events associated with manipulation, the Cochrane Back and Neck Group have highlighted further investigation of mobilisation as a research priority. Additionally, with little information available about which are the most effective techniques and approaches to mobilisation, the Cochrane Group has recommended future research also focus on addressing this question. There are currently two distinctly different approaches to cervical spine mobilisation for people with neck pain. A pragmatic approach is based on the assumption that individualised treatments, with key dosage parameters determined by careful assessment of pain and movement are important determinants of outcome. A prescriptive approach is based on the assumption that standardised techniques and dose are effective, and that patient selection is the main determinant of outcome. This pilot study will investigate the feasibility of a trial to determine whether a pragmatic or a prescriptive approach to cervical spine mobilisation more effective in relieving pain and restoring function in people with recent onset neck pain

The primary purpose of this trial is to evaluate the safety and efficacy of venetoclax in combination with chemotherapy for the treatment of acute myeloid leukaemia (AML) in elderly patients. Who is it for? You may be eligible to participate in this trial if you are aged 60 or over with monosomal karyotype, or aged 65 or over with any karyotype, and have been diagnosed with AML for which you have received no induction chemotherapy. Study details All participants enrolled in this trial will be administered Venetoclax in combination with modified-dose chemotherapy. The dose provided will depend on the time of enrolment - each sequentially enrolled group of participants will be administered with a slightly higher dose than the previous group, pending a review of the safety of the previous dose. Participants will have an induction treatment consisting of 14 days Venetoclax tablets, 5 days IV Cytarabine and 2 days IV Idarubicin. For participant achieving a response to treatment there will be up to 4 further cycles of 14 days Venetoclax, 2 days Cytarabine and 1 day Idarubicin or until adequate blood count recovery. Participants will be assessed through blood samples taken daily during initial hospitalisation and then at the end of each cycle of treatment, bone marrow samples taken 3 times during induction and then every other cycle as well as a physical exam every cycle in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the AML. It is hoped that the findings of this trial will provide information on the optimal dose of Venetoclax in combination with chemotherapy for the safe and effective treatment of AML in elderly patients.

Exercise training is commonly used for the treatment and prevention of many chronic diseases. Of particular interest are the effects of exercise training to prevent many age-related changes, including reduction in blood vessel health and whole body fitness. Healthy older adults will be recruited to participate in an 8 week exercise training program where they will be randomised to one of three different cycle training groups: moderate intensity double-leg continuous cycling, high intensity double-leg interval cycling, or high intensity single-leg interval cycling. Measures of blood vessel function, heart structure and function, fitness and body composition will be obtained at baseline, 4 weeks (blood sample and vessel function only), 9 weeks and 16 weeks.