ANZCTR search results

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

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31193 results sorted by trial registration date.
  • Preventing Osteoporosis in Patients with Spinal Cord Injury (SCI)

    Osteoporosis is a major cause of morbidity in patients with spinal cord injury (SCI) and is under-recognised in this population. Osteoporosis is universal in SCI sufferers and typically results in pelvic and lower limb fractures which heighten the risk of limb contracture, pressure sores, local bone complications including infection and non-union and thus, increases complication and death rates in this population. The primary aim and objective of this prospective study is to try and prevent the occurrence of osteoporosis in acute SCI. This aim involves early assessment of musculoskeletal parameters in SCI patients within 8-12 weeks following an acute traumatic spinal cord injury, and the use of a preventative treatment with an already approved osteoporosis drug to prevent the rapid bone loss which occurs in the acute phase of the spinal cord injury.

  • Development of a database and biobank facility for the collection of clinical data and the storage of biological samples, such as tissue, blood and urine, in patients with bladder and urothelial cancer (BLADDA).

    The purpose of this study is to determine whether certain biomarkers have an impact on the effectiveness of treatment of bladder cancer. Who is it for? You may be eligible for this study if you are over the age of 18 and have been diagnosed with muscle invasive bladder cancer or metastatic bladder cancer. Study details All participants will be required to give blood and urine samples at predetermined time points while completing their own cancer treatment. Where possible, blood collection will be at the same time as routine blood tests to reduce the number of times blood is taken. If there is left over tissue after planned medical procedures then a sample of this tissue will be kept. The blood, urine and tissue samples will then be tested to determine how the cells, genes and immune system interact with the cancer and whether these relate to treatment results. It is hoped that this research will help us to better understand why some bladder cancers are more aggressive than other and also why some treatments work better in some patients than others.

  • Study to assess the safety and effectiveness of propagermanium as add-on therapy in FSGS patients who are already taking Irbesartan.

    Eligible patients will randomly assigned (50/50 chance) to receive both the propagermanium and placebo in different orders as follows, either: 1. Treatment Period 1: Propagermanium capsule twice a day for 16 weeks Treatment Period 2: Placebo capsule twice a day for 16 weeks. OR 2. Treatment Period 1: Placebo capsule twice a day for 16 weeks Treatment Period 2: Propagermanium capsule twice a day for 16 weeks. This study will determine how safe and effective propagermanium is in the treatment of paients with FSGS by: • monitoring symptoms that patients may experience while on the study • measuring levels of protein in patients urine and kidney function during the course of the study. • measuring the levels of propagermanium and irbesartan that enters into patients blood • comparing the propagermanium result to patients' pre-study and placebo results

  • Intensive rehabilitation for people with hereditary cerebellar ataxia.

    This study aims to compare the effectiveness of an intensive rehabilitation program (consisting of a six-week outpatient rehabilitation program followed by a supported home exercise program (HEP)) compared with standard care on motor function in individuals with hereditary cerebellar ataxia. The study will be a multi-centre randomised controlled trial. The intervention group will receive outpatient rehabilitation three days per week for six-weeks followed by 24 weeks of a supported HEP (fortnightly teleconference/home visits), while the control group will be asked to continue their current care for 30 weeks. Rehabilitation will be based on six domains of rehabilitation: strengthening, balance, functional mobility practice, postural control, sensory stimulation and coordination and control, and will include land and aquatic physiotherapy. Assessment will occur at baseline, and six, 18 and 30 weeks after baseline. The primary outcome will be the motor domain of the Functional Independence Measure. Secondary outcomes will measure ataxia symptoms, quality of life, balance and patient perceived benefit.

  • The mind-body relationship of common physical symptoms in the community.

    Multiple somatic symptoms (MSS) can be defined as a range of non-specific symptoms such as musculoskeletal pain, fatigue and abdominal pain, and are expressed in the absence of any clear pathology. MSS is measured on scale. Those who score highly on that scale are associated with a reduced quality of life and substantial increase in healthcare utilisation. By way of example, disorders such as Somatization Disorder (Diagnostic and Statistical Manual of Mental Disorders-V), fibromyalgia, chronic fatigue syndrome, functional Gastrointestinal disorders and multiple chemical sensitivity have all been associated with MSS. This study focuses on MSS, rather than specific diseases or only a few symptoms. It is important to do so, as MSS is considered to be a predictor of negative health consequences, independent of other chronic diseases or psychopathology. For the present study, MSS are identified using the Patient Health Questionnaire-15. At present a large proportion of Australians seek help for MSS, which places a burden on generalist and specialist services. In addition, the natural course of MSS is unfortunately unfavourable (meaning that symptoms suffered by people with MSS are less likely to resolve with time). By way of comparison, MSS stability rates are as high as depressive disorders and higher than anxiety disorders. However, to date, limited research of MSS has been conducted in an Australian community setting. Identifying, the prevalence of MSS in the community and related psychological predictors of its development and maintenance remains an important health priority. The present study seeks to address the following aims: 1. To determine the incidence and prevalence of MSS in an Australian community setting and its relationship with co-morbid chronic diseases, specific illness related cognitions and psychological distress. 2. To determine the stability of MSS over the course of 1 year. 3. To suggest potential psychosocial aetiologies for MSS by studying mind-body and body-mind interactions in these conditions.

  • Clinical trial comparing two surgical techniques used to treat instability of the ankle in those people who are normally involved in sports activities.

    Background: “Ankle sprain” is a common injury, and more than 20% of patients may develop chronic instability for which surgery is indicated. The modified Brostrom-Gould (MBG) procedure remains the gold standard, but there are a number of relative contra-indications to this procedure and the longer term outcomes following the MBG have been questioned. An alternative procedure is augmentation of a primary repair with a ligament augmentation reconstruction system (LARS). What is known about the subject: Ankle sprains of the lateral ligaments are the commonest sport-related injury and approximately one quarter of patients have on-going symptoms of instability. The MBG procedure is the gold standard treatment but a significant number of patients have relative contraindications for this procedure, and there is a paucity of scientific evidence to support its popularity or long term efficacy. What this study may add to existing knowledge: A primary repair augmented with a synthetic ligament may result in a better patient-scored outcomes than the MBG and may not have the same relative contraindications. The use of this synthetic ligament to augment a primary repair may represent a safe and effective surgical alternative for management of ankle instability. However its efficacy need to be compared with that of the gold standard procedure, the modified Brostrom-Gould procedure (MBG). This ligament has been used for this indication before but there is no level evidence 1 or 2 to support its use. Study Design: Prospective Randomized Controlled Clinical Trial Methods: Patients who satisfy the inclusion criteria will invited to take part in the study. Patients are randomly allocated to undergo the LARS procedure or MBG procedure. Both groups will follow a similar post-operative rehabilitation. Patients completed the Foot and Ankle Outcome Score (FAOS) before surgery, and then at 1, 2, 5 and subsequent years following surgery. Tegner activity scores are also recorded. The scores in the two groups will be compared using statistical analysis (P<0.05).

  • Advancing automated insulin delivery for exercise to improve the daily lives of people with type 1 diabetes

    Participants with type 1 diabetes will undertake three exercise stages, in random order, while they receive automated insulin dosing delivered via an insulin pump. The types of exercise to be undertaken are: (i) moderate-intensity exercise; (ii) short bursts of high-intensity exercise; and (iii) resistance exercise using weights. The changes in biochemical parameters, body movement and heart rate during the three types of exercise will be compared. This information will ultimately be used to refine the computer program controlling automated insulin delivery for people with type 1 diabetes when they are exercising.

  • Linking Brain Vascular Function with Neurobehavioral Function in Obstructive Sleep Apnoea

    Obstructive sleep apnoea (OSA) is a condition in which the upper airway collapses during sleep, leading to episodes of sleep fragmentation and hypoxemia. OSA has been linked to a decrease in neurocognitive function in some patients and potentially to the development of dementia, however the mechanisms remain unclear. This clinical study will investigate the link(s) between cerebrovascular response to hypoxemia, arterial stiffness, brain tissue hypoxia and neurocognitive function in OSA patients, before and after 8 weeks of CPAP treatment.

  • The feasibility of prescribing a walking program to improve physical functioning of people living in the community after hip fracture.

    Hip fracture is a common and serious fracture affecting older Australians, with high risk of ongoing disability. After hip fracture many people have very low levels of physical activity. There is evidence that increasing physical activity has many health benefits, but this is challenging for people after hip fracture due to pain, fatigue, psychological factors and co-morbidities. Preliminary studies from our team have investigated the amount of physical activity that people can tolerate after hip fracture without adverse effects. In the community, we determined that people after hip fracture could safely and feasibly complete 100 minutes of moderate intensity walking in a week. This proposed randomised controlled trial will determine whether prescribing this amount of physical activity (100 min/week) in addition to usual care is a feasible and effective intervention for improving health outcomes in this patient group. It is hypothesised that completing 100 min/week of prescribed walking is feasible for people recovering from hip fracture and effective in improving functional independence.

  • Dietary fibres and gut microbiome response in obese subjects

    Obesity and its associated metabolic diseases are closely linked with the gut microbiome which is significantly affected by the amount and type of dietary fibre consumed. Reviews have identified broad effects on the gut microbiome with consumption of dietary fibre, but recognise that differentiation between the effects of individual fibres is required. Although fibre is referred to as a single entity in nutrient reference values and other dietary guidance systems, fibres vary significantly in chemical composition and their physico-chemical properties in turn affect their physiological actions. This research will investigate these fibres individually in order to enhance understanding of their influence in the relationship between obesity and the gut microbiome. This pilot project will be of crossover design with randomised order of dietary intervention in up to 20 obese subjects with anthropometry indicating metabolic risk (BMI >30 kg m-2 and waist circumference indicating metabolic risk). Four separate dietary interventions will occur, each of 3 weeks (including a low fibre control, two moderate fibre cereals- sorghum and oats and a high fibre cereal- oats) and there will be a 3-week washout between test phases. We will measure effects of increased cereal fibre intake and of different cereal types, on the microbiome, body weight, percent body fat and serum levels of short chain fatty acids (SCFA) and lipopolysaccharides (LPS). SCFA levels will be modulated (higher levels of some SCFA modulated by the type of fibre) by changes in dietary fibre intake and previous research demonstrates that SCFA are part of the mechanism by which metabolic outcomes are improved. The LPS will act as a marker of toxicity which we would expect to decrease with improved diet. Using microbiome changes as the primary outcome will provide insight for ongoing studies to determine doses of fibre and types of fibre that may have positive benefits on health outcomes due to a mechanism involving the microbiome. We expect beneficial effect of increased dietary fibre intake and reduction of aversive effects associated with obesity. We propose that positive changes in the gut-microbiome can be detected after relatively short periods of time and that change is related to the type of fibre increased in the diet, not just the amount of dietary fibre. We hypothesise that this mechanism is associated with changes in SCFA and LPS (which has been linked with positive health outcomes).

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