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Effects of mild brain stimulation in children with attention deficit hyperactivity disorder (ADHD)
Expand descriptionApplying a mild electrical current to the head is known to improve brain functions related to attention and learning without causing significant adverse side effects other than a mild local skin irritation at the stimulation site. The current study investigates stimulation effects whilst children - diagnosed with mild to moderate attention deficit hyperactivity disorder - undergo their regular occupational therapy.
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PumpTune computer recommended insulin pump settings compared to Doctor advised settings in children with Type 1 Diabetes: A randomised controlled trial
Expand descriptionInformation from continuous glucose sensors is complicated. Insulin pumps can be set in many ways and the settings are complicated and may vary depending of the person making the changes. This study compares the results after insulin pumps are adjusted by a doctor or by a computer program.
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The securement and dressing of percutaneous central venous access devices (CVADs) in the paediatric intensive care: a pilot randomised controlled trial
Expand descriptionChildren admitted to a paediatric intensive care unit (PICU) frequently require the insertion of a CVAD for the administration of medication and fluids. These CVADs are associated with a high rate of failure, including CVAD-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU), are used to protect the CVAD insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), sutureless securement devices (SSD), and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for CVAD. It is not known whether these new products are effective at reducing CVAD failure, in comparison to standard care (BPU and suture). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on CVAD failure due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with percuteanous CVAD in the PICU.
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Trial of KPT-330 in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL)
Expand descriptionThis study will determine whether selinexor has any effects against Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL). Who is it for? You may be eligible to join this study if you are aged 18 years or above and Relapsed or Refractory PTCL or CTCL Study details This study drug, selinexor, works by trapping “tumour suppressing proteins” within the cell and thus causing the cancer cells to die or stop growing. Selinexor has previously been tested in humans to define a safe dose to be administered. It is not known at this time if selinexor will treat PTCL/CTCL. This study will examine the effects of selinexor on PTCL/CTCL and look at the side-effects. After signing the consent, participants will undergo screening assessments up to 30 days before the first dosing. These include: medical and medication history taking, eye examination, ECG, Echocardiogram or MUGA scan, chest X-ray, CT/MRI scans, tumour or skin biopsy, bone marrow aspirate or biopsy, height, weight, vital signs measurement, physical exam, and urine and safety blood tests. Eligible participants will receive oral selinexor tablets on Days 1 and 3 of Weeks 1-3 of each 4-week (28 day) cycle (6 doses/cycle) until disease progression or intolerability. The dose of selinexor will be either 100mg or 80 mg depending on the participants’ body surface area (calculated from their height and weight). Participants will also take dexamethasone to improve selinexor tolerability and antinausea drugs (e.g. ondansetron) to minimise nausea. Additional anti-nausea and anti-anorexia agents may be given as needed. The assessments done at screening will be repeated at various intervals to monitor safety and assess efficacy of the selinexor. In addition, photographs of skin lesions (CTCL patients only) will be taken and blood samples will be taken to check the level of selinexor in the blood at certain timepoints, and to test the binding of selinexor in the blood. Follow-up visits will occur 30 and 60 days after the last dose of selinexor, then participants will be contacted every 3 months to check on their disease status and other treatments.
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Dressing and securement of peripherally inserted central catheters (PICCs) in paediatrics; a pilot, randomised controlled trial
Expand descriptionChildren admitted to an acute care facility frequently require the insertion of a peripherally inserted central catheter (PICC) for the administration of medication and fluids. These PICCs are associated with a high rate of failure, including PICC-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU) and sutureless securement devices (SSD), are used to protect the PICC insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for PICC. It is not known whether these new products are effective at reducing PICC failure and complication, in comparison to standard care (BPU and SSD). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on PICC failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with PICC in acute care.
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Single Ascending Dose and Multiple Ascending Dose Phase I study of PXS-4728A Administered Orally in Healthy Adult Males.
Expand descriptionThis is the first in human study with PXS-4728A. The primary aim of the study is to establish the safety and tolerability while the secondary aim is to understand the pharmacokinetics and pharmacodynamics of PXS-4728A in healthy males.
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Follow up of immunogenicity and safety of acellular pertussis vaccine given at birth to 4 years of age
Expand descriptionThis study is the third phase follow up at 4 years of age of subjects who received neonatal acellular pertussis vaccination. This study looks at safety and immunogenicity of pertussis vaccination, and extends knowledge from the first phase (birth to 13 months) and the second phase (18-24 months).
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Treatment of Clinical Depression in Overweight & Obese Adults: A Tailored Cognitive Behavioural Approach.
Expand descriptionThe proposed study will investigate the efficacy of a tailored 10 week CBT program with minimal exercise intervention vs combined CBT and novel exercise intervention. Depression is a common mental illness, affecting up to 1 in 7 Australians in their lifetime with the third highest burden of all diseases in Australia (i.e. total impact of disease measured by financial cost, mortality, morbidity and other indicators) and the number one cause of non-fatal disablity in Australia. Research has shown that inidividuals who are overweight or obese have higher rates of depression than normal weight peers and that individuals who are depressed are more likely to be overweight or obese than non-depressed peers. The use of exercise has proven to be an effective intervention for depression although a limited number of studies have been performed using a RCT.
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A psychoeducation intervention for family caregivers of people with dementia using a mobile application: a feasibility study
Expand descriptionAims This study aims to: 1) develop and examine the feasibility and effect of a psycho-education intervention delivered via mobile application for family caregivers of people with dementia on caregiver burden, coping strategies, depression, gain in caregiving, distress caused by BPSD, and frequency and severity of BPSD over a 3-month follow-up; and 2) examine family caregivers’ appraisal and perceived benefits of the intervention. Hypotheses Primary outcomes When compared with the routine care control group across two time points (immediately and 3-month post intervention), the intervention group will have significantly: lower level of caregiver burden, and higher level of coping strategies. Secondary outcomes When compared with the routine care control group across two time points (immediately and 3-month post intervention), the intervention group will have significantly: lower level of depression, higher level of gain in caregiving, lower level of distress caused by BPSD, and reduction in the frequency and severity of BPSD
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Effect of commercial mouthwashes versus water and savacol on level of gingival inflammation and plaque accumulation in healthy adults: A parallel randomized placebo controlled single-blind clinical study.
Expand descriptionParticipants between the age of 18 – 35 yrs old that fulfill the inclusion criteria will be chosen to take part in the study. All participants will be randomly assigned to one of six groups 14 days prior to commencement of the study. All the participants will receive a dental clean and will be advised to stop the use of their regular mouthwash. When the experiment begins (day 0) participants will be advised to follow the experimental oral hygiene protocol. And they will be advised to use one of five mouthwashes (or water which is a negative control). Five different gum measurements will be measured and the soft tissue health will be noted at all four visits from the start of the experimental period. At the last visit participants will be requested to fill a questionnaire form as well. In addition they will also receive a dental clean to remove bacterial accumulation on their teeth and extrinsic tooth staining. There is significant evidence in the current literature that commercial alcohol containing mouthwashes such as Savacol (Registered Trademark) and Listerine (Registered Trademark) reduce bacterial accumulation and gum inflammation. However despite some progress, there is a huge gap in clinical evidence demonstrating the efficacy of commercially available non-alcohol containing mouthwashes such as Savacol (Registered Trademark), Listerine Zero (Registered Trademark) and a herbal mouthwash – Dr Organics Aloe Vera (Registered Trademark) mouthwash, in the prevention of bacterial accumulation and gum inflammation. This study is expected to give us more evidence about the benefits that these non-alcohol containing mouthwashes can provide to our patients.