ANZCTR search results

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

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31214 results sorted by trial registration date.
  • 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.

  • Clinical study investigating the safety PG545 in combination with nivolumab in patients with advanced solid tumours and in patients with metastatic pancreatic cancer

    This study will determine the safety and tolerability of PG545 in combination with Nivolumab in patients with advanced solid tumours or metastatic pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years old or above and have a non- haematological, malignant solid tumour (for Stage 1) or metastatic adenocarcinoma of the pancreas (for Stage 2). Study details This study has two stages: Stage 1 to establish the maximum tolerated weekly dose of PG545 intravenous (IV) infusion in combination with fortnightly Nivolumab IV infusion, and stage 2 to safety and tolerability of the recommended dose from stage 1 of PG545 IV infusion in combination with fortnightly Nivolumab IV infusion. Treatment in both stages will continue until disease progression, unacceptable toxicity or participant withdrawal. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. It is envisaged that the combination of PG545 and Nivolumab will improve on the limited treatment options currently available for patients with pancreas cancer. Once demonstrated to be safe, the combination can then be explored in larger clinical studies in pancreas cancer and other tumour types.

  • Do commercially available sunscreen indicators assist in sun protection in healthy adults?

    The goal of this study is to investigate whether commercially available UV indicating stickers are acceptable to users and encourages sun protection. Commercially available cosmetic products have been developed and marketed direct to consumers, which use a UV light activated (photochromic) ink to illustrate that sunscreen is no longer protecting their skin adequately. To assess this product and if it adds any benefit for future public health programs we are conducting a study at the Ashes Cricket Test at the Brisbane Cricket Ground, commonly known as the Gabba, which is a major sports stadium in Brisbane. The event is being held November 23rd – November 27th 2017. The researchers will be at the venue entry and will ask interested members of the public to consent to participate before they enter the stadium. Participants in the intervention group will be asked to complete a brief baseline survey and be provided with 1 sticker and sunscreen. After using the sticker at the cricket, participants will be emailed an evaluation survey to complete. Participants will have 7 days after using the sticker to complete the evaluation survey. A comparative control group will be provided with sunscreen only (no stickers).

  • Stereotactic ablative body radiotherapy for Unresectable Pancreatic cancer with Endoscopic ultrasound inserted fiducial markers and concuRrent chemotherapy (SUPER) trial.

    This study will determine the effect of stereotactic ablative body radiotherapy (SBRT) with endoscopic ultrasound inserted fiducial markers for unresectable pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have adenocarcinoma of the pancreas which has been deemed inoperable and are planning for treatment with combined chemotherapy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive chemotherapy only In this trial, patients receive a FOLFIRINOX based regime given over a 4 month period (oxaliplatin, irinotecan, leucovorin, fluorouracil every 2 weeks, totalling 8 cycles). While participants in the other group will receive chemotherapy of Folfirinox based regime and they will also receive 2 weeks of Capecitabine as a radio-sensitizer (850 mg/m2 twice daily for 5 days of each week (Monday to Friday)), prior to fiducial guided SBRT (25Gy in 5 fractions delivered to gross tumour and simultaneous integrated boost of 35Gy in 5 fractions to region of vessel encasement). Participants will be followed-up for up to 12 months post-completion of treatment to determine survival rates, resectability rates, technical success of fiducial placement, pain and quality of life. The use of radiotherapy, either alone or in combined with chemotherapy, has been evaluated in the past but evidence is limited due the lack of ability to deliver the radiation to the pancreatic mass without causing adverse effects to surrounding organs. One of the approaches to overcome this problem is to use marker-guided stereotactic radiotherapy, which is increasingly applied in the field of radiation oncology. The majority of studies have looked at technical success and safety rather than patient survival and quality of life.

  • At their fingertips: The effects of child-led distraction using a tablet computer on children’s distress and pain during painful medical procedures; a randomised controlled trial.

    Managing pain and distress for hospitalised children undergoing medical procedures is very important as it reduces the occurrence of paediatric medical traumatic stress and other significant negative outcomes (Lindeke et al., 2006). Evidence has shown that non-pharmacological interventions such as distraction are a highly successful method in reducing distress and pain in adult and paediatric patients. At present, paediatric patients undergoing painful procedures do not routinely receive distraction therapy due to limitations such as time. With modern technology rapidly evolving, research designed to assess the effectiveness of child-led distraction using a tablet computer in reducing distress and pain in children undergoing painful medical procedures is essential. Through exploring this, a valuable contribution may promote the therapeutic practice and improve health care outcomes for children and their families. The results of this study will assist in determining whether child-led distraction through the use of a tablet computer (Apple iPad) reduces distress, pain and procedural time by incorporating a wide range of distraction methods in one convenient and cost-effective device.

  • Use of ultrasound in cannulation of haemodialysis vascular access and affect on needle placement and cannulation success.

    Comparing the use of ultrasound for cannulation of arteriovenous fistula for haemodialysis compared to the standard practice of cannulating 'blind' (without assistance of ultrasound) and measuring the outcomes in relation to the amount of success with each condition and the needle tip position inside the vessel. All nurses in the study will cannulate all patients with both ultrasound guided cannulation and blind cannulation.

  • Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting Children’s Early Self-Regulation Development

    Using Community-Based Participatory Research (CBPR) methods, the completed first Phase of the Early Start to Self-Regulation project engaged key stakeholders in formative research (Phase 1; HE2017/029) to inform the design and piloting of a self-regulation intervention (Phase 2; HE2017/347). This next phase involves implementation and evaluation of our self-regulation program (Phase 3). Phase 3 will involve recruiting 50 pre-school centres, half of which will implement the PRSIST self-regulation program while the other half continues with normal practice. Data on children’s self-regulation, as well as related abilities, will be collected from participating children before and after implementation of the program to evaluate its impact. Data will also be collected from participating educators regarding their perceived self-regulatory knowledge, attitudes and self-efficacy related to self-regulation, both before and after the program, to evaluate change.

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