ANZCTR search results

The primary purpose of this trial is to evaluate the accuracy of PSMA-PET/CT scans for determining the stage of prostate cancer and planning treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with prostate cancer for which you have not yet received treatment, but it is planned that you will undergo surgery or radiotherapy. Study details: All participants enrolled in this trial will be randomly allocated (by chance) to receive either the conventional scans (CT + bone scan), or the PSMA-PET/CT scan which is being evaluated. All patients will cross-over to second-line DI (crossover to other arm) unless the disease status for distant metastases was positive (ie. not equivocal or negative) with >2 sites of disease demonstrated. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course. The accuracy of the scans will be determined by using follow-up information available up to 6 months after entering the study. If the scans showed abnormalities or your doctor has clinical suspicion of prostate cancer, the scans will be repeated at 6 months. In patients with normal PSMA PET/CT scans, follow-up data may be collected at 18 30, 42 and 54 months (the study will stop 3 years after randomisation of the last patient).

The study is evaluating the potential of a shared-care model of follow-up for survivors of colorectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more, have a confirmed diagnosis of colon or or rectal cancer at stage I-III, completed treatment with curative intent within the past 3-months at one of the participating sites and have a GP willing to participate in the study. Trial details: Participants in this trial are randomly (by chance) allocated to one of two groups. Participants in Group 1 will receive usual care according to current hospital practice. Participants in Group 2 will receive shared-care between specialist and general practitioner in which two routine hospital appointments will be replaced by GP appointments. In addition participants in Group 2 will receive a tailored survivorship care plan with care guidelines detailing information and recommendations about common concerns after treatment with additional support services information. Once the survivorship care plan is complete the patient will receive a written copy, with a copy provided to the patients preferred General Practitioner (GP). This is to ensure that the GP is familiar with the issues the patient is working on and can provide ongoing assistance as necessary. All participants will be asked to complete some questionnaires at the start of the study, and 6 and 12 months later in order to assess unmet needs, perceived experience of oncology care, satisfaction of the intervention and quality of life. Feasibility and cost-effectiveness of the two interventions will also be assessed.

The primary purpose of this study is to determine how the diagnosis of a bowel condition at colonoscopy/upper gastrointestinal condition at endoscopy, impacts quality of life, and whether this changes between diagnosis and one year later? We would also like to investigate the differences in the quality of life for those who have experienced surgery and/or neoadjuvant therapy, for colorectal, oesophageal or gastric cancer, within 3 years of treatment. Who is it for? Participants for this study will be people who have had a colonoscopy within the last two weeks, who have a diagnosis of one of the following at colonoscopy: (1) bowel cancer (stages I, II, III or IV), (2) advanced adenoma, (3) small non-advanced adenoma, (4) non-neoplastic findings (such as diverticular disease or haemorrhoids) or (5) no pathology detected (normal colon). People who have had an endoscopy within the last two weeks, who have a diagnosis for one of the following: (1) inflammation, (2) polyps, (3) oesophageal varices, (4) ulcers, (5) coeliac disease (6) Barrett’s oesophagus, (7) gastric cancer (stages I, II, III, IV), (8) oesophageal cancer (stages I, II, III, IV), or (9) no pathology detected, are also eligible. Also, for those who have had prior treatment for colorectal, oesophageal or gastric adenocarcinoma (stages I, II, III or IV) within the last 3 years. Study details: All study invitees will be sent via mail a study invitation letter and a questionnaire within two weeks after their colonoscopy appointment. The questionnaire contains questions about health conditions, health-related quality of life and well-being, attitudes toward managing health and other basic demographic questions (including age, education level and country of birth). A two week period will be allowed following the mail out of letters for return of completed questionnaires. If the questionnaire has not been returned during this time, then research staff will make telephone contact with the study invitees to follow-up and confirm their willingness or otherwise to participate in the study. Those who complete the questionnaire will be invited to complete the same questionnaire 12 months later. Individuals who have had prior treatment for colorectal, oesophageal or gastric cancer, within 3 years, will be sent the same information, an invitation letter, participant information sheet and consent and a once-only questionnaire. Follow-up telephone contact will also be initiated, should there be no response after two weeks. The invitees are given the option to withdraw from the offer of participation by telephone or withdrawal form, at any time. It is hoped that the findings of this trial will provide health related quality of life data for different bowel and upper gastrointestinal conditions and experiences in the Australian population. This can then be used in health economic modelling to assess the cost effectiveness of bowel cancer screening.

The sponsor has developed a wafer formulation of buprenorphine to be administered under the tongue. The buprenorphine wafer will be compared to intravenous buprenorphine (marketed in Australia as Temgesic). Healthy volunteers may participate in the study. Participants will complete two inpatient sessions, with admission the afternoon before dosing, followed by 48 hours of observation after dosing. Participants will receive a single dose of intravenous buprenorphine 300mcg during one inpatient session and a single dose of sublingual (under-the-tongue) buprenoprhine wafer 800 mcg during another session. Naltrexone is given to block opioid effects. The two inpatient sessions will be separated by a minimum of 7 days. No food will be allowed for 10 hours prior to and four hours following dosing.

This short-term, randomised, 3 period, crossover study, which will be conducted in our purpose-built, sound-isolated laboratory at the Woolcock Institute. Because of rising community concerns about the health effects of infra sound generated by wind turbines we will measure the impact of exposure to infrasound on multiple dimensions of human health in individuals who report increased noise sensitivity.

Aim The aim of the study was to determine length of time from tension-free vaginal tape procedure to discharge can be shortened by using the infusion method trial of void rather than the standard auto-fill trial of void. Background Tension free vaginal tape (TVT-exact) procedure is a commonly performed continence procedure for urodynamic stress incontinence. At present, prior to discharge home, standard practice at our institution requires completion of a trial of void (TOV). Protocols differ between institutions, but generally a TOV requires overnight admission. However in some centres, it is routine practice to send patients home within 2 hours of the operation if they have passed urine. The nature of the surgery does not require patients to undergo an extended period of observation. Currently, our practice is to empty each patient’s bladder upon completion of surgery. The time to initial void is then dependent on the rate of urine production for each patient. This process is termed “auto-fill”. The alternative method is called the “infusion” method, where the bladder is filled with a predefined volume at completion of surgery to facilitate a shorter time until first postoperative void. The infusion method has been studied in several trials and is safe for patients and effective at predicting which patients will have post-operative voiding dysfunction in gynaecology patients. (Kleeman S, Goldwassar S, Vassallo B. Predicting postoperative voiding efficacy after operation for incontinence and prolapse. Am J Obstet Gynecol 2002;187:49, Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 Techniques to Predict Voiding Efficiency After Inpatient Urogynecologic Surgery. J Urol 2010;184:1408) However these studies are not powered to find a significant difference in time to complete TOV. The TOV process will begin in the recovery area of theatre. If the patient passes the TOV within 2 hours and they are otherwise well, they will be discharged home from recovery. If they have not passed their TOV within 2 hours, they will be transferred to the ward for continuation of the process. Recovery and ward nurses assessing the TOVs will be blinded as to which group the patient belongs to. Unlike previous studies, patients will also be blinded as to which group they have been allocated to. Inclusion Criteria Patients consented to undergo a TVT-exact procedure at Robina Hospital. Exclusion Criteria Patients with urodynamic study proven detrusor overactivity, mixed urinary incontinence or voiding dysfunction. Preoperative postvoid residual of >150ml Patients who cannot be booked as a day case i.e. patients with a medical or social reason preventing discharge on the day of operation. Epidural/spinal anaesthesia Neurological conditions affecting the lower urinary tract Bladder perforation at the time of TVT placement or other incidental pathologies diagnosed at time of surgery such as interstitial cystitis, malignancy or calculi. Patients undergoing any other concomitant procedure. Primary Outcome Discharge within 2 hours of the end of the operation. Secondary Outcomes Time taken to complete trial of void Successful trial of void Continued self catheterisation or in-dwelling catheterisation beyond ten days post operation Follow up 1. 2 week gynaecology outpatient appointment to confirm absence of voiding dysfunction: a post void residual with a bladder scanner 2. Routine 6 week postoperative appointment.

This study is testing the effectiveness of a 4-month nurse-moderated, group-based internet intervention for mothers experiencing mild to moderate levels of depression. The intervention was delivered to mothers when their infants were aged 2-6 months and outcomes are being evaluated when infants are aged 8 months and 12 months. There were 133 mothers and infants recruited to the trial, 72 of whom received the internet based program, whilst the remaining families received standard care. The outcomes for the project include maternal depressive symptoms, maternal caregiving, parenting competence, service utilisation, and intervention quality.

Patients who undergo cardiac surgery are routinely cared for in the intensive care unit immediately following their operation. During part of the surgery, the patient’s circulating blood is diverted through a machine that essentially replicates the function of the heart and lungs (cardiopulmonary bypass). This occurs so that blood can be diverted from the heart so that the surgeon can operate safely. At this point the patient is cooled to prevent damage to the brain and heart that may occur whilst their blood circulation is dependent on cardiopulmonary bypass. Patients are transferred to the intensive care unit still cold (hypothermic) and warm up passively and through external warming blankets with time. However, hypothermia can last for hours, have adverse effects, such as inhibiting the blood’s normal clotting mechanisms, and causing shivering and is made worse by the common administration of room temperature fluids. Low blood pressure (hypotension) is a common problem encountered in patients during cardiac surgery and also in the intensive care unit afterward. If untreated, hypotension can lead to dysfunction of vital organs and even death. Often the first intervention to treat low blood pressure is administration of intravenous fluid into the patient’s vein. Typically, a discrete volume (e.g. 500 ml) is given rapidly as a “bolus” to improve the patient’s blood pressure. The rationale is that the intravenous fluid will increase the patient’s blood volume, leading to an increase in blood pressure and cardiac output (volume of blood pumped by the heart over one minute). It is common practice for patients to receive fluid that has been warmed to normal human body temperature (37oC) whilst in the operating theatre to prevent the adverse effects of hypothermia. However, common practice in the intensive care unit is to administer intravenous fluids that have been stored at room temperature (approximately 20 – 22oC). The use of room temperature fluids is likely to worsen hypothermia and therefore potentially increase the risk of bleeding, as well as causing shivering – which may require the administration of sedative medications. Given the above concerns, the intensive care consultant group will be introducing the use of warmed intravenous fluid bolus therapy to patients cared for in the intensive care unit following cardiac surgery. After such introduction of warm fluid therapy, we plan to systematically audit the haemodynamic impact of this practice change. Importantly, we will audit the feasibility of this practice change and ensure whether it achieves our intended aim of decreasing the time taken for patients to warm up to a normal body temperature. In addition, we wish to assess whether, as expected, a warmed bolus of fluid therapy results in a different effect on blood pressure as compared to a bolus of identical volume of room temperature fluid. This audit will take a similar path to the recent conservative oxygen therapy trial, where a practice change allowed slightly lower than usual oxygen levels to be targeted at Austin Hospital, a before and after audit was conducted and showed clear benefits in patient outcomes including an increase in earlier spontaneous ventilation thus leading to the embedding of such therapy into practice based on clear data from the quality improvement cycle. The introduction of warmed fluids will follow the same quality improvement assessment cycle.

MyTime is a national program of facilitated peer support groups for parents and carers of children (aged up to 16 years) with a disability, developmental delay or chronic medical condition. The program was established in 2007 by the Parenting Research Centre (PRC) and is funded by the Australian Department of Social Services (DSS). The PRC are planning to conduct an evaluation from July 2015 until 2020 to understand how well the program is meeting the needs of participants and to further develop and support the implementation of MyTime in collaboration with partner agencies, with the aim of improving the program for parents and carers. Specifically, the evaluation aims to determine: 1. Whether MyTime is being implemented as intended; and 2. The effect of MyTime on the intended proximal outcomes of the program. Continuous Quality Improvement (CQI) is a systematic approach to continuously collecting and reviewing data or information about the implementation of an intervention in order to identify opportunities to improve this implementation, with the end result of delivering better services to clients. This process enables implementers to collect, interpret and use data in a continuous process to ensure that the core elements of the intervention are being adhered to and delivered as intended (fidelity), monitor outcomes for families receiving the intervention and evaluate the true effectiveness of the intervention by accounting for implementation variability. To test the acceptability of the outcomes and dynamic fidelity measures and to test data collection systems, an initial pilot study will be conducted consisting of up to 30 participants (MyTime members and facilitators) drawn from 2-3 representative MyTime groups. As part of the ongoing CQI evaluation, data collected through routine practice and via a brief survey/telephone interview with MyTime coordinators will be utilised to assess agency adherence to basic program elements (structural fidelity). The quality and content of the relationship between interventionists (MyTime facilitators) and members (parents and carers) (dynamic fidelity) will be measured using a brief questionnaire that is administered to all current MyTime members and facilitators. Both fidelity measures will be completed on a six-monthly basis. Finally, new MyTime members will be invited to participate in an outcomes evaluation which involves the completion of a brief questionnaire within one month of commencing MyTime and a follow-up questionnaire six months later. The questionnaires include information on family demographics, parent knowledge of supports and level of perceived support, parenting confidence, parent well-being and respite needs. The second questionnaire will repeat all but the demographics questions. Both existing and new MyTime members and facilitators will be provided with a plain language information sheet and consent form inviting them to participate in the dynamic fidelity and outcomes evaluation.

Impairments in social relating are a core feature of autism spectrum disorder (ASD). Neuroimaging research suggest that this may be underpinned by abnormal activation with the right temporoparietal junction (rTPJ), which is a brain region that is important for social understanding (including recognising other's mental states and making social inferences). We have previously demonstrated that repetitive transcranial magnetic stimulation (rTMS) to another part of the "social brain" network, the dorsomedial prefrontal cortex (dmPFC), can improve social aspects of ASD. Our recent neuroimaging work, however, suggests that rTPJ is a more appropriate target than dmPFC. This study will involve theta burst stimulation (TBS), which is a newer form of rTMS that has several advantages over traditional rTMS protocols. TBS treatments are quick (3 minutes) and delivered at a low stimulation intensity (thereby reducing participant discomfort). Adolescents and young adults with ASD (n = 20) will completed a randomised, single-blind cross over study comparing TBS to the rTPJ with TBS to the dmPFC. Participants will be administered intermittent theta burst stimulation (iTBS), which can enhance brain activity and strengthen brain network connections. Participants will undergo various assessments before and after undergoing each of the TBS conditions, including magnetic resonance imaging, clinical interviews, and computerised experimental psychology tasks.