ANZCTR search results

To properly manage type 1 diabetes, individuals are required to measure blood glucose levels (BGL's)regularly and adjust the amount of insulin to be given accordingly. This has been done by matching the amount of insulin with the amount of carbohydrate in a meal. Recent studies have shown that meals high in protein can also significantly increase the BGL. There are recommendations that additional insulin be given with meals containing high levels of protein to prevent post prandial hypergycaemia (elevated BGL's after a meal). However, at this time there is insufficient data to determine how these additional insulin doses should be calculated. A current algorithm used to calculate additional insulin based on protein content in a meal has been shown to cause unacceptable levels of hypoglycaemia. We will recruit 31 people with type 1 diabetes between the ages of 7 and 40 years diagnosed for more than 1 year, using either insulin pump therapy or multiple daily injection therapy. Participants will have a glycated haemaglobin of <8.5% and body mass index <91st centile. Exclusion criteria will be those with co-existing medical conditions. The aim of this study will be to: Define the impact of variable protein loads on post prandial BGL's up to 8 hours. The participants will be contacted daily for the first week to monitor BGL's and adjust insulin doses. A continuous glucose monitoring system (CGMS) which provides continuous measurement of BGL's will be inserted on the first day. For 5 consecutive days participants will be instructed to eat a standardised evening meal containing consistent quantities and type of carbohydrate. The participant will give a standard insulin bolus for the carbohydrate in the meal. They will then be instructed to eat a test meal (protein shake) 4 hours after the evening meal. The participant will fast over night and check the BGL in the morning prior to eating breakfast. If the participant has has a BGL <3.5 mmols/L or has symptoms of hypoglycaemia at any time they will eat 15 grams of carbohydrate as per their usual management. During the test meal study days exercise and evening food will be standardised.

Research question: Does therapeutic ultrasound reduce the severity of rhinosinusitis in adults with cystic fibrosis (CF)? Methods: Adults with CF and chronic rhinosinusitis will be randomly allocated to receive ultrasound or sham ultrasound in a hospital outpatient clinic, 6 times in 2 weeks. The primary outcome will be the severity of rhinosinusitis symptoms, measured using the 22-item Sino-Nasal Outcome Test after the treatment period. Secondary outcome measures will be peak nasal inspiratory flow, lung function, global rating of change, a generic health-related quality of life questionnaire, medication use, and adverse events. Measurements will occur during and 6 weeks beyond treatment. Significance: This study will determine whether therapeutic ultrasound reduces rhinosinusitis symptoms in adults with CF to a clinically worthwhile extent and whether any effect extends beyond the treatment period. Growing evidence indicates that sinusitis seeds the lower respiratory tract with infection, so an effective rhinosinusitis treatment may also have respiratory benefits, which are crucial for people with CF. Ultrasound use has decreased since it was shown to be ineffective for many conditions. If the study shows ultrasound is effective for CF rhinosinusitis, physiotherapists’ apply their skills and this equipment to treat CF rhinosinusitis.

The Analgesia nociception index (ANI) is a novel score aiming to enable anaesthetists to estimate pain perception in anaesthetized patients. It work via 2 sticky (single use) electrodes applied to the chest (like ECG electrodes) from which it derives ECG data. This is then transformed into an index from 0-100, the ANI which will be larger in states of comfort and smaller in states of more pain. Although non-invasive and risk free, very few data exist to show the association of ANI with standard measures of nociception/pain in unconscious subjects: changes in blood pressure, heart rate or patient movement. We aim to do an observational trial on 30 patients in which we attach ANI monitoring to anaesthetized patients, record the ANI score continuously and match these records with other patient data obtained at the same time (blood pressure, heart rate, patient movement). This should enable us to get a better idea about the predictive value of ANI changes to preempt changes in above mentioned standart observations.

The primary aim of the study to evaluate the effectiveness of MPD as a monotherapy and adjunctive antidepressant treatment in patients with melancholic depression who have failed orthodox antidepressant options. Key Hypotheses: 1. Those receiving MPD and an antidepressant will show superior responder and remission rates compared to those receiving an antidepressant only 2. Those receiving MPD monotherapy will show comparable remission and responder rates to those in Group 2 (a non-inferiority hypothesis). 3. Those receiving MPD will improve more rapidly than those on antidepressants only 4. Substantive side-effects and drop-out rates will be lowest for patients on MPD only.

This study is an observational study investigating the use of new tracer for Positron Emission Tomography (PET). This tracer is preferentially taken up by cells that undergo rapid proliferation. The study has two aims: to assess the feasibility of conducting a larger trial, and to assess the sensitivity and specificity of FLT PET. The target patient population is those with locoregionally advanced mucosal head and neck squamous cell carcinoma undergoing definitive chemoradiation. You may be eligible to join this study if you are aged 18 and over, and have a previously untreated biopsy proven mucosal head and neck Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx - Stage III or IV (TNM staging). You must be suitable for definitive radiotherapy + concurrent systemic treatment. Further details on the inclusion criteria for this study can be found in the relevant section on this form. Trial details All participants in this trial will undergo their standard cancer treatment, but with the addition of 2 18Fluoro-L-Thymidine and Positron Emission Tomography (FLT-PET) scans at baseline and at week 3 of radiotherapy. This will involve injection of FLT (study tracer) with scan commencing 60 minutes later.

The broad aim of the project is to test the effectiveness of a new service program to be made available to mothers of young children. The unique feature of the program is that it will combine the skills of community nurses and web-based technology to enhance support for mothers of infants. Following the development of the new program, it's effectiveness will be tested in trial involving approximately 800 mothers and infants. Half of the mothers and infants will receive the combined program while the other half will receive routine care provided for by CaFHS. We will test whether the combined program achieves equivalent outcomes to that achieved by routine care. The outcomes this project will assess include levels of parenting self-efficacy, perceived support, maternal mental health, infant development and the quality of mother-infant attachment.

Those randomised to the intervention group will receive the services of a Mobile Rehabilitation team who will deliver rehabilitation services while the participant is admitted to the acute wards. Those randomised to the control group will have usual care. Both groups will be followed up by phone interview at 3 months for those with moderate injury and 6 months for those with severe injury to determine health outcomes.

This study in pregnant women with asthma investigates the maternal, infant and childhood outcomes following asthma treatment adjustment using FENO, compared to standardised usual care treatment adjustment.

The central aim of the study is to determine if Evoked Compound Action Potentials (ECAPs) can be recorded during Deep Brain Stimulation (DBS). During the DBS lead implant procedure, specialised stimulating and recording equipment will be connected to the lead. Routine stimulation will be applied to the implanted lead electrodes and neural responses (ECAPs) will be recorded from the adjacent electrodes. Measurement of the ECAP responses may provide information to improve the implant procedure and stimulation programming, and provide information on the mechanisms of DBS.

Traditionally patients presenting to hospital with a heart attack are hospitalized for at least 5-7 days to monitor for complications such as increasing shortness of breath, recurrence of chest pain and fast irregular heart rate and also to increase their medications and receive a basic understanding of future management of their chest pain. A randomized trial in Canada showed that early discharge from hospital for low risk heart attack patients was feasible and safe when combined with close nursing follow up at home. We propose to randomize low risk heart attack patients to early discharge (<72 hours) with hospital-in-the-home (HITH) nurses and doctors compared with conventional 4-5 day stay in hospital. The aims of this study are 1. To prove that an early discharge strategy is safe and acceptable to patients with no increase in deaths, adverse events or unexpected readmission to hospital 2. To evaluate the patients’ experience and quality of life in both groups using questionnaires. 3. To examine the cost effectiveness of early discharge from hospital to HITH versus conventional 4-5 day hospital stay. Patients presenting to Box Hill Hospital with a heart attack and have undergone coronary angiogram and are treated with either medical therapy such as medications or angioplasty and stent will be screened using validated tools to assess for low risk. They will then be randomized to either early discharge with HITH (intervention group) or conventional 4-5 day hospital stay (control group). About 300 hundred patients will be recruited for the trial. The intervention group will be discharged from hospital before 72 hours and followed up daily by HITH nurse for at least 3 days. In the first week they will be reviewed by the HITH consultant doctor at the Maroondah clinic. The control group will be discharged home according to standard care at day 4 or 5. The main outcomes to be measured are: all-cause death, readmission or re-presentation to hospital due to chest pain, recurrent heart attacks or heart failure, as well as procedural and non-cardiac complications related to the index event at 30 days. The information will be gathered via phone interviews and medical records. Health-related quality of life and patients’ experiences of in-patient care will be evaluated using validated questionnaires. A telephone call to all patients at 6 weeks and 3 months will remind them about completing the questionnaires, and include a brief interview regarding re-presentation to the hospital, readmission, compliance with medications, attendance at cardiac rehabilitation and smoking cessation. All information collected will remain confidential and be de-identified for research purposes. The cost-effectiveness (reduced length of stay) of the early discharge strategy will also be analysed.