ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32850 results sorted by trial registration date.
  • Transarticular tibio-talo-calcaneal nailing versus open reduction and internal fixation for treatment of the elderly ankle fracture: a multi-centre, prospective, randomised controlled trial.

    This is a surgical study comparing traditional methods of ORIF (plates and screws) versus a new technique of hindfoot nailing in elderly patients with ankle fractures. The proposed benefit of hindfoot nailing is that participants can put weight through their ankle earlier, however it locks the ankle and does not allow it to move. At this point in time it is unknown which technique has better outcomes.

  • Prenatal screening for aneuploidy in the Australian Public Hospital System; a Non-Invasive Prenatal Screening Test (NIPT) feasibility study.

    This study will offer the cell free fetal DNA blood test, NIPT, to all pregnant women visiting the Nepean Hospital Perinatal Ultrasound Department who have singleton pregnancies and have been referred for their combined first trimester screening test for Down syndrome risk. Once they have agreed to participate in the study, All will receive genetic counselling via either face-to-face consult or web-based education. The participants in the study will undergo their first trimester screening test, consisting of ultrasound and serum biochemistry, free ßHCG and PAPP-A, regardless of their choice to undergo NIPT. The NIPT will be offered to them free of charge. The aim is to include 1000 patients. The proposed time line is twelve months, with nine months of data collection and three months to complete analysis and write up results. The primary aim is to define the uptake of NIPT in the Australian Public Hospital system. A secondary aim is to compare the overall cost to the healthcare system of offering NIPT as a first line screening test for Trisomy 21 to the current contingent model in detecting each correct diagnosis of Trisomy 21. Analysis will include the detection rate of screening, results and outcomes as well as the cost per ‘correct’ result, taking into account extraneous factors such as additional need for further counselling for false positives, invasive procedures and losses due to invasive procedures. The efficacy of each protocol (NIPT versus the contingent model) using a dollar value per correct case detected, will also be determined. The tertiary aim will be to analysis the effectiveness of alternative methods of genetic counselling in providing appropriate education and support will be compared to the traditional face to face model. Hypotheses to be tested: That there will be a large uptake of NIPT within our population after either type of counselling. That both traditional counselling as well as web based counselling will be effective counselling methods and will enable patients to make an informed decision regarding their first trimester screening. That performing NIPT as the preferred method of screening for Down syndrome might be more cost effective to the public system compared to the current model.

  • Treatment of Adult Amblyopia with the Vivid Vision System

    The Vivid Vision system is a commercially available device for the treatment of amblyopia. The system is a virtual reality headset connected to a PC with motion and hand detection software. The Vivid Vision software gives the user tasks where they must use their hands and fingers to point to or move objects that they see in the VR headset. The colour, size, contract and clarity of these objects are altered depending in the person’s performance in the tasks. The company claim that this immersive but controlled experience is extremely effective for treating amblyopia. Vivid Vision make claims that with regular use of the system there is a benefit for children with amblyopia. These claims are reasonable and within accepted ophthalmic standards. The company also claims that the system can benefit adults with amblyopia. Such claims are contrary to the generally accepted belief that there is no treatment for adult amblyopia. It is important to subject these claims because • If the Vivid Vision system does in fact help adults with amblyopia improve their amblyopic eye then this is a huge breakthrough. We must be able to offer adults this treatment if it is effective. • If the Vivid Vision system is not effective then it is important that the company’s claims are subjected to closer scientific scrutiny. The patients will be identified from the clinician's existing population of patients Physical examination • Patients will be examined by an ophthalmologist, Dr Brendan Cronin and an orthoptist to ensure that there is no strabismus and that none of the exclusion criteria are met. There will be a full dilated retinal examination, colour vision assessment, stereopsis testing and refraction. Electrodiagnostics • An objective visual acuity will be performed at the Queensland Electrodiagnostic and Imaging Clinic at 140 Melbourne Street South Brisbane. Vivid Vision Training • Participants will have 30-60 minutes of training on the Vivid Vision system once per week • The system is an Oculus Rift virtual reality headset exactly like those that are used in computer game systems. After 6 and 12 months participants will have the electrodiagnostic testing done again. At 6 and 12 months they will have an examination by Dr Cronin and an orthoptist as well for refraction and stereoacuity testing.

  • What effect do different physiotherapy managements of the upper spine have on breathlessness and lung function following exercise in people with COPD?

    COPD is the fifth greatest contributor to the overall burden of disease in Australia. Breathlessness is the primary symptom that limits exercise in people with COPD. Reduced exercise is associated with higher hospitalisation rates and increased mortality rates. Lung hyperinflation which is characteristic in COPD contributes to spinal rigidity which may further contribute to exertional breathlessness and subsequent reduced exercise capacity. Previous research has shown that manual therapy has immediate effects on reducing breathlessness and improving lung function. There is a known link between joint mobilization and SNS function showing immediate effects on local and centrally mediated pain, muscle and SNS function. It may therefore be hypothesized that improvements in pain and muscle function would be associated with reduced spinal rigidity, potentially improving lung function and reducing breathlessness. Several studies that have pharmacologically inhibited SNS activity have reported reduced breathlessness, so it might also be hypothesised that thoracic mobilisation may have a similar effect on breathlessness. To the best of our knowledge no studies to date have investigated the impact of manual therapy on lung function or breathlessness associated with a functional relevant activity such as walking. This study aims to investigate, in people with stable COPD who experience exertional breathlessness, whether a single treatment involving 6 minutes of Grade III central PA accessory joint mobilisation of the thoracic spine decreases breathlessness and improves lung function more than a placebo intervention. We hypothesis that joint mobilisation of the thoracic spine will decrease breathlessness and improve lung function following a 6 minute walking exercise task. If proven successful, this may permit patients to exercise more frequently and at higher intensities optimizing the benefits of exercise. This along with the potential to increase participation in physical activity may lead to a reduction in exacerbations, hospital admissions and associated cost savings.

  • A phase 1, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenous CMX-020 in healthy male and female subjects

    This is a Phase I, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose, single-center study to evaluate the safety and tolerability, and describe the pharmacokinetics of escalating single doses of CMX-020 administered as a 15-minute intravenous infusion to healthy male and female subjects. The study population will be comprised of up to 48 healthy male and female subjects aged 18-50 years, inclusive, considered eligible on the basis of study inclusion and exclusion criteria. Each subject who meets eligibility criteria will be randomly assigned to receive CMX-020 or placebo. Each escalating dose group will consist of 8 subjects; 6 will be randomized to receive a single dose of CMX-020, and 2 will be randomized to receive a single dose of placebo. Treatment groups will be dosed in an escalating order, each dose level increased by no more than 2-fold over the previous dose level. The decision to escalate the dose will be based upon review of the safety and EEG data for all subjects in each previous dosing panel. No subject will receive more than one dose of study medication.

  • Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after Bone Marrow Transplant

    The aim of this project is to evaluate the Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after Bone Marrow Transplant. Who is it for? You may be eligible to join this study if you have persistent or relapsed B-cell malignancy post related donor allogeneic stem cell transplant and a donor willing and available to donate peripheral blood for the generation of CAR19 T-cells. Study details Matched related donor derived CAR19 T-cells will be administered intravenously after lymphodepleting cyclophosphamide and fludarabine. This T-cell therapy may be administered alone or in addition to salvage chemotherapy. Three CAR19 T-cell dose levels will be assessed within each patient: 1x10^7cells/m^2, 5x10^7cells/m^2 and 1x10^8/m^2. Dose escalation will be determined 4 weeks after the last dose dependent on persistence of disease, no severe toxicity and falling CAR19 T-cell numbers. Patients will be monitored for early and long term toxicity, persistence of CAR T-cells and disease response. If successful, this treatment will enable the widespread application of CAR19 T-cells to patients with few other effective treatment options.

  • Deferiprone for the Treatment of Parkinson’s Disease

    In Parkinson’s disease, there is a loss of the cells that produce dopamine, a chemical that sends signals between brain cells, and this leads to problems in movement and other functions. Drugs exist that act to increase levels of dopamine, but while doing this may relieve symptoms, it does not have any impact on the underlying cause. Patients with Parkinson’s disease have been found to have a build-up of extra iron in the brain. While some iron is necessary for good health, too much of it can be toxic, and it is possible that the symptoms of Parkinson’s disease are due at least in part to extra iron acting to destroy the dopamine-producing cells in this brain region. Deferiprone is an iron chelator, meaning that it binds to free molecules of iron in the body and moves them or gets rid of them. This study is looking to see if giving this drug to Parkinson’s patients will act to remove the extra iron from the brain and so prevent further destruction of dopamine-producing cells, thereby slowing progression of the disease. A total of 40 patients in different countries will be enrolled. Both patients who are already on standard antiparkinsonian medication and patients who have not yet started on such medications will be enrolled, in order to see how other treatments affect the response to deferiprone. All subjects will receive deferiprone twice a day for 9 months. The dose will be 15 milligrams (mg) of deferiprone for every kilogram of body weight, for a total daily dosage of 30 mg/kg. Patients will undergo regular tests to check the safety of the drug and to see if it is acting to slow disease progression, as assessed by the change from baseline in scores on a scale that measures the severity of Parkinson's disease symptoms. In addition, because a possible side effect of deferiprone is a drop in a certain type of white blood cell, patients must have their blood tested weekly, but this can be done at a local laboratory.

  • BRAin Cancer and Exercise (BRACE) Study.

    The aim of this study is to determine the suitability and safety of an 18-week exercise program for people with brain cancer and to test whether the program improves quality of life, well-being and physical health. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a diagnosis of primary malignant brain tumour (i.e. brain cancer). Study details During the 18-week intervention, Accredited Exercise Physiologists (AEP) will prescribe weekly exercise that will be individualised according to the your interests, fitness, presence of treatment-related side effects and co-morbidities. The exercise program will include aerobic (cardiovascular) exercise, and resistance (strength) based exercise. The AEP will prescribe and monitor exercise type, duration and frequency every week and modify prescription according to symptoms and gradually progress the exercise prescription. You may choose to do all exercise sessions under the supervision of an AEP at Aspire Fitness and Rehabilitation (at Woolloongabba, Brisbane) or have some exercise sessions supervised and other unsupervised (at home or another convenient location). Assessments (questionnaires and physical assessments) will be conducted at baseline, the middle (week 9), the end of the of the program (week 18) and 6 months later. We hypothesise that participants will feasibly and safely participate in an 18-week individualised exercise intervention.

  • App-Based Supplemental Exercise During Inpatient Rehabilitation Increases Activity Levels: A Randomised Control Trial

    Objective: To investigate whether an App-based supplemental exercise program in inpatient rehabilitation will increase activity levels and improve functional outcomes and be acceptable to participants Design: Single-centre, single-blind pilot randomised control trial Setting: Inpatient private general rehabilitation unit Participants: Up to 140 individuals admitted for inpatient rehabilitation over 3 month duration. Intervention: Participants will be randomised to receive supplemental exercise via an App (PTPalTM) on a tablet device additional to usual care or usual care alone. Main Outcome Measures: Total repetitions of each activity and time in supplemental exercise programs, participant satisfaction with App-based supplemental exercise. Secondary measures were 10 Metre Walk Test (10MWT); 6 Minute Walk Test (6MWT); Timed Up and Go (TUG); total amount of inpatient therapy hours, Functional Independence Measure and length of stay assessed by a blinded assessor.

  • The use of negative pressure in the treatment of secondary arm lymphoedema and fibrosis in post-breast cancer patients

    The main aim of this study is to assess the use of Physiotouch in treating secondary arm lymphoedema and tissue fibrosis in patients who have undergone unilateral surgical treatment for breast cancer. Participants will be females who have had breast cancer and have undergone unilateral mastectomy. Key exclusion criteria woman who: has received breast-cancer related treatment within the last 6 months, is pregnant, younger than age 18, have implantable devices, have heart problems, have a tendency to clot, or are predisposed to infection. Study details: Participants will not need to change any current conservative therapy they are receiving for their lymphoedema or tissue fibrosis. The PhysioTouch device will be use to administer treatment by professionals trained in the use of this device. All participants will be receiving the same treatment. This study will assess the possibility of Physiotouch, and negative pressure, being used as an alternative therapy to the current conservative management for lymphoedema and tissue fibrosis which only uses positive pressure.

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