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.
  • Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease

    The aim of the current study is to investigate whether adding nivolumab and ipilimumab after chemoradiotherapy helps to stop small cell lung cancer coming back. You may be eligible for this study if you are an adult with confirmed small cell lung carcinoma. If the study is suitable for you, you will commence treatment with chemotherapy and thoracic (chest) radiotherapy and prophylactic cranial irradiation (PCI/ brain) radiotherapy which are the standard of care treatment for SCLC. Following completion of the chemotherapy and radiotherapy part of your treatment you will have a CT scan to see if your cancer is shrinking or growing. If your cancer has grown your consulting doctor will discuss the most suitable treatment for you at that time. If your cancer has not grown, you will go on to the next part of the study, and you will be randomised into one of two study groups: Group 1: Nivolumab plus ipilimumab (experimental treatment) Group 2: Observation (no further treatment) If you take part in STIMULI, you will have a number of tests at the first study visit to confirm that the study is suitable for you. At each study visit, you will have various assessments, such as blood testing, urine testing. Computerised Tomography (CT) scans to assess your cancer will be performed every 2-3 months for the first 2 years and then less frequently. This study will help researchers understand how well this treatment works and how severe the side effects are of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment (chemotherapy and radiotherapy) followed by immunotherapy (nivolumab and ipilimumab) in patients with limited SCLC.

  • Correction of preoperative iron deficiency in children undergoing elective spinal fusion. A Randomised control trial of Intravenous Iron vs. Oral Iron therapy.

    This study aims to evaluate whether intravenous iron is superior to oral iron in correcting preoperative iron deficiency in children undergoing posterior spinal fusion surgery. As there is often a limited time window between patients being booked for surgery (and undergoing preoperative screening) and their surgical date it is important to determine what is the more effective treatment method. The null hypothesis states that there is no difference between oral and IV iron therapy in the incidence of severe anaemia at the time of discharge following elective spinal fusion surgery. The primary outcome measure is the incidence of severe anaemia (haemoglobin <100g/L) at the time of discharge from hospital.

  • Does general anaesthesia with xenon gas improve protection of the brain when compared to general anaesthesia with a standard anaesthetic agent?

    In this research project we will be comparing anaesthesia with xenon to anaesthesia with our usual anaesthetic agent, sevoflurane. Xenon has been used as an anaesthetic agent for many years but it’s use is limited because it is so expensive. In order to justify its use there needs to be good evidence that it has a significant benefit. One area in which xenon appears to have benefit is in protecting the brain during anaesthesia and surgery. There is growing evidence that having an anaesthetic and surgery can cause some problems with how the brain functions. This is of particular concern in infants and older people. This study is considering if there is evidence that xenon may be more protective of the brain than the usual anaesthetic. For the study, patients having a minor surgical procedure will have anaesthetic with either xenon or sevoflurane. We will take blood tests from both sets of patients. The blood tests will look for evidence of any harm to the brain cells of the patients to identify if one anaesthetic is better than the other.

  • 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 bladder cancer or urinary tract 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 and urinary tract 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.

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