ANZCTR search results

Aim: To determine in a proof-of-concept study if re-purposing existing approved medications that target the sleep/wake system and upper airway muscle control reduce sleep apnoea severity. Research design: randomised, double -blind, placebo-controlled, cross-over. Methods: Participants will be required to attend 2 overnight visits, each separated by 1 week in the sleep laboratory. Standard sleep monitoring equipment will be applied including: electrodes on the surface of the head, face and chest to monitor wakefulness and sleep, a sensor placed on the finger to monitor oxygen levels, bands placed around the chest and abdomen along with airflow sensors or a mask over the nose to monitor breathing. Participants will be randomised to receive either a placebo (sugar pill) or a combination of two medications (betahistine 96 mg + oxybutynin 5 mg) just prior to sleep.

Individuals with Parkinsons Disease typically experience changes to speech and voice associated with poor breath support. While it may be hypothesised that breathing exercises could improve communication function, available evidence does not support this. Expiratory Muscle Strength Training (EMST) devices encourage a specific style of breathing training, where individuals must use maximal strength of expiration to overcome a high level of resistance. It is hypothesised that this high challenge is more likely to lead to gains than training without a device. Training with EMST in isolation has seen improvements in voice and speech in some other populations. There is no known evidence to support its use for people with Parkinsons Disease. This case series (2 participants) study aims to determine if there perceptual change to voice volume/quality, or speech articulation following intensive training with an EMST device, with nil co-occurring therapy, in people with Parkinsons Disease.

This study is investigating whether it is safe to add a blood pressure medication to standard immunotherapy treatments for metastatic melanoma (melanoma that has spread to other body organs or systems). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with metastatic or unresectable melanoma, you are eligible to receive Nivolumab and Ipilimumab as per local standard of care for the treatment of melanoma, and you have not received any prior systemic (whole body) cancer therapies within the past 6 months. Study details All enrolled participants will be asked to take a single Perindopril oral tablet, once daily for up to 2 years. Participants will be asked to continue taking the oral tablet throughout their immunotherapy treatments which will be scheduled as: Ipilimumab 3mg/kg intravenous infusion every 3 weeks for 4 cycles Nivolumab 1mg/kg intravenous infusion every 3 weeks for 4 cycles Nivolumab 480mg intravenous infusion, every 4 weeks for up to 2 years, commencing 6 weeks after the last dose of Nivolumab 1mg/kg. You will have a blood test before each treatment to make sure it is still safe to give the treatment. Throughout the trial you will have routine CT scans of your chest abdomen and pelvis every 12 weeks to check if the cancer has shrunk or grown. You will also have a ultrasound of your heart before you commence treatment, after 1 month and then every 3 months for 2 years to make sure that there are no issues with your heart. It is hoped this research will determine that adding perindopril to standard immunotherapy treatments for patients with melanoma is safe and effective. The results of this study may lead to improved heart health outcomes for future melanoma patients if the added medication is shown to be safe.

This study is aiming to assess the effect of a smoking cessation program called ‘Care to Quit’ on smoking behaviours in people with cancer who smoke. Who is it for? You may be eligible for this study if you are over 18 years of age, have been diagnosed with any form of cancer in the last 6 months, and have used combustible tobacco (e.g. cigarettes) in the past 90 days. Study details The proposed study employs a stepped wedge randomised trial design involving the recruitment of cancer patients across 9 centres. In a stepped wedge design, all hospitals begin in the control condition and then move to the intervention condition at randomised intervals. During the control phase, hospitals will deliver ‘treatment as usual’ smoking cessation support (which will vary depending on hospital site usual practice). The intervention involves a ‘Care to Quit’ program, which involves training health professionals in how to deliver and implement best practice smoking cessation care in their hospitals. This process will be tailored to hospital sites. All participants will receive a number of surveys about their smoking behaviours and well-being at the beginning of the study, and 7 months later. It is hoped that this program will improve smoking abstinence in cancer patients, and contribute to formation of guidelines that aid healthcare workings in helping cancer patients to quit smoking.

.This study involves the comparison of 2 diets in women with endometriosis experiencing concomitant gut symptoms. The aim is to ascertain if one of the diets assists in reducing gut symptoms.

The aim of this study is to determine the effects of salt restriction in people with type 2 diabetes and chronic kidney disease treated with the sodium-glucose co-transporter 2 inhibitor, empagliflozin compared with treatment with empagliflozin alone during liberal sodium intake. We hypothesise that in people with type 2 diabetes and chronic kidney disease treated with empagliflozin, salt restriction results in a greater reduction in 24-hour ambulatory blood pressure compared with liberal salt intake.

This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, vs placebo, to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects. Participants will attend two visits at which they will receive either STW5-II or placebo, and gastric relaxation will be measured for the following three hours. The hypothesis is that STW5-II will increase proximal gastric relation.

Vaporised nicotine products (VNPs or electronic cigarettes) hold significant potential as both cessation aids and harm reduction support for people who smoke tobacco. There is now good evidence of safety, and emerging evidence that VNPs assist cessation. More evidence of the safety and effectiveness of VNPs for populations (such as persons who use drugs) with high smoking prevalence rates and low quit rates is desperately needed. Further it is important to determine the efficacy of novel strategies compared to current best practice treatment, Nicotine Replacement Therapy (NRT). The aim of this trial is to test the effectiveness of VNPs at increasing smoking cessation amongst opiate agonist treatment (OAT) clients receiving treatment at alcohol and other drug (AOD) services across NSW Local Health Districts/Networks (LHD/Ns), compared to current best practice treatment (NRT). Service users from six LHD/Ns across NSW will be recruited and randomised.

Poor adherence to osteoporosis management guidelines is associated with a higher fracture risk, with increases in subsequent utilisation of health care services and their associated health care costs. We will recruit 50 postmenopausal women with osteoporosis who have current prescriptions for anti-osteoporosis medication. We will randomly allocate 25 women to receive a voice-controlled intelligent personal assistant (VIPA) device (Amazon Alexa) that will provide regular medication reminders and education related to fracture risk factors, a home-based exercise program, and nutritional advice (delivered using both audio and video functions of the VIPA device), for six months. The remaining 25 women will receive general information about managing osteoporosis via monthly emails. We will compare osteoporosis self-management behaviours (medication adherence, physical activity and dietary nutrient intakes) in both groups for 12 months. We will also assess usability and acceptability of VIPAs in the intervention group. We hypothesise that women randomised to the VIPA intervention group will demonstrate greater anti-osteoporosis medication adherence, higher physical activity levels and greater intakes of protein and calcium compared with women in the control group.

A vaginal vault haematoma formation is a recognised complication of a hysterectomy and can be associated with post-operative infection, bleeding, pain, discharge, ileus, prolonged hospital stay or readmission, or even return to theatre. The aim of this randomised controlled trial is to evaluate the rate of sonographically proven vaginal vault haemotoma following a total laparoscopic hysterectomy with and without the use of TISSEEL. As secondary endpoints the rate of complications associated with a vaginal vault haemotoma post-TLH will be assessed including: re-admission, blood transfusion, vault infection requiring antibiotics, and return to theatre. Participants will include females aged 18 and over undergoing a total laparoscopic hysterectomy for benign pathology on theatre lists at the Gold Coast University Hospital under the supervision of the Gynaecology Director. After consenting, they will be randomly allocated with a 1:1 ratio. If the Director deems the use of TISSEEL is necessary due to the clinical situation then the participants will be excluded from the trial. Participants will be followed up with a phone call questionnaire regarding complications and undergo an ultrasound scan to evaluate for a vault haematoma.