ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Efficacy, feasibility and acceptability of a dual treatment approach for anxious children who do not respond to first-line psychological treatment

    Current psychological treatments for child anxiety are well-established and evaluated, yet up to half of children still have an anxiety disorder after treatment. According to guidelines by RANZCP, following unsuccessful treatment with a psychological program, children should be moved to a course of SSRI medication. While this sounds like a logical suggestion, it is currently not based on any scientific evaluation. The aim of this pilot study is to evaluate both the effectiveness of this approach and its implementation in the Australian community. Children aged 7-12 years who have current anxiety disorders will be treated with a scientifically tested psychological program in university services. Following this, children who still have a diagnosable anxiety disorder will be randomly allocated to either treatment as usual (continued practice of learned skills) or will receive a referral with detailed information recommending SSRI treatment to their current medical practitioner. Improvements in diagnoses, anxiety symptoms and life impairment will be assessed 15 weeks later, along with feasibility, acceptability and other implementation data such as how many medical practitioners agree to prescribe.

  • Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins (FEASST) Study: An Australian partner study conducted in male twins

    The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on sperm quality, integrity, content and epigenetic programming. Participants will receive dietary interventions of either a processed western dietary intake pattern - the “processed diet”, or an unprocessed, whole foods dietary intervention meeting the Australian Dietary Guidelines - the “unprocessed diet”. The main purpose of these interventions is to determine how and if the semen quality and epigenetic state of sperm are altered based on acute changes to dietary intake in men of reproductive age. We are specifically interested in determining how nutrient intake alters the epigenetic state of sperm, in a manner that has the potential to affect the development and health of offspring. This study will strengthen our understanding of how paternal lifestyle prior to conception may play a role in influencing the health and epigenetic status of future generations. It is hypothesized that men on the unprocessed diet versus men on the processed diet will induce different epigenetic changes to the sperm at regions involved in development and metabolism.

  • Effect of acute exercise on endocannabinoid and mood responses in adults with cancer: A pilot study

    This study aims to compare the effect of a single bout of exercise on endocannabinoid (eCB) and affective (mood) responses in adults with cancer currently receiving chemotherapy treatment versus their healthy peers, and to evaluate relationships between eCB and mood responses to exercise. Who is this study for? You may be eligible for this study if you are a cancer patient aged 18 or older, and currently receiving chemotherapy treatment; and if you are an apparently healthy adult (age 18+) . Study details All participants will engage in a single testing session involving seated rest (30 min) followed by a moderate exercise bout on treadmill or exercise cycle (30 min). Participants will be asked to fill in mood surveys and provide blood samples before and after the seated rest and exercise conditions. It is hoped that findings from this study will help inform future trials investigating the benefits and barriers to exercise in cancer patients.

  • Identification and Multidisciplinary Prehabilitation of at Risk Elderly patients undergoing colorectal cancer therapy (IMPRovE). A feasibility scoping study to implement a prehabilitation programme at Western Health

    Currently, frailty is rarely identified prior to surgery and patients undergoing colorectal cancer surgery do not have prehabilitation optimization at Western Health (WH). Recent investigations of our WH population have identified poorer functional outcomes and lower quality of life associated with this population which indicated unmet psychosocial and occupational performance needs. With this study, we plan to introduce a novel approach to tailored treatment in our most at-risk group of patients. Who is it for? You may be eligible for this study if you are an adult who has a planned surgery for primary colorectal cancer at Western Health. Study details All patients enrolled in this study will undergo a frailty assessment and be prescribed a pre habilitation to be completed over a period of 4 weeks. This prehabilitation program will include nutritional adjustment by a dietician and improvement of exercise function by physiotherapy. Patient quality of life questionnaires, food diary, nutritional and physical fitness assessment will be carried out by dieticians and physiotherapists. It is hoped that this study will show that it is feasible for frail and at-risk colorectal cancer patients undergoing surgery to undergo prehabilitation. This aims to improve strength, mobility and flexibility, reduce frailty, and improve post-operational outcomes such as length of stay.

  • Characterising gaze patterns during driving among people who use methamphetamine

    This research will investigate whether long-term methamphetamine use produces changes to driving ability in the absence of acute intoxication, and whether this can be effectively indexed and monitored through objective markers of performance. Using our high-fidelity driving simulator with advanced simultaneous eye-monitoring technologies, we will use real-time analysis of head position and eye movements to examine the relationship between gaze vector and driver behaviour to better understand the impact of methamphetamine addiction on driving performance in separate groups of 1.) individuals who use methamphetamine and 2) healthy adults who have no history of the use of psychostimulants and have no history of chronic/binge use of psychoactive substances. We expect that there will be a measurable difference in the patterns of eye movements displayed during driving by individuals who use methamphetamine versus those who have no history of the use of psychostimulants or no history of chronic/binge use of psychoactive substances

  • Saving Legs & Lives: Cardiovascular rehabilitation following leg vascular surgery.

    Peripheral artery disease is an atherosclerotic disease characterised by blocked arteries and impaired blood supply to the legs, which causes muscle pain and limits waking capacity and the ability to undertake daily activities. People with peripheral artery disease may undergo lower limb revascularisation to improve or restore leg blood flow. Supervised exercise is an effective therapy that can improve walking capacity and quality of life in people with peripheral artery disease. Supervised exercise training following lower limb revascularisation can further enhance the clinical outcomes of the revascularisation procedure. This is a randomised-controlled trial which will assess the efficacy of a community-based cardiovascular rehabilitation program versus usual care on exercise capacity and quality of life in people who have undergone lower limb revascularisation for peripheral artery disease. If successful, this trial will lead to improved clinical outcomes for people undergoing lower limb revascularisation for peripheral artery disease. This study will provide crucial knowledge for the inclusion and integration of patients with peripheral artery disease into community-based cardiovascular rehabilitation exercise programs.

  • Dental and Skeletal Changes Following Bone- and Tooth-borne Maxillary Protraction with Miniscrews and Class III Elastics

    The intervention involves placing four miniscrews (two on the maxilla and two on the mandible) which the frameworks will be fitted over, Class III elastics attached to the frameworks will be worn full-time until the skeletal Class III malocclusion is corrected. The aim of this trial is to evaluate the dental and skeletal changes of skeletal Class III patients treated with Bone- and Tooth-borne Maxillary protraction with Miniscrews and Class III Elastics. The null hypothesis is that there will be no dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics, when comparing the pre- and post-treatment situation. The alternative hypothesis is there will be a dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics.

  • A digital health education program promoting physical activity for childhood cancer survivors: A hybrid effectiveness-implementation trial of 'Making Moves'

    This study aims to assess the effectiveness of a distance-delivered digital health program on improving physical activity self-efficacy among childhood cancer survivors aged 8-21 years, and to explore the barriers and facilitators to program uptake in these participants. Who is it for? You may be eligible for this study if you are aged between 8-21 years of age, you were diagnosed with cancer as a child prior to age 18 years, and you have completed active cancer treatment at least 6 months prior to the time of study participation OR is receiving maintenance therapy. Parents and caregivers of participants will also be asked to participate in interviews after delivery of the program. Study details All participants who choose to enrol in this study will be given access to an online co-designed program that includes evidence-based health behaviour education and physical activity engagement modules. Participants will be able to access the education modules and view physical activity videos at any time over an 8 week period. Participants will also be scheduled to attend up to 5 telehealth/online video consultations with an Accredited Exercise Physiologist. These consultations will be scheduled prior to participants gaining access to the online program, week 2 or 3 of the program (optional), at week 9 post-program completion, at 3-months and 6 months following program completion. Each consultation will be approximately 60 minutes and will be individualised to the participant and will include exercise assessments, health behaviour education, tailored goal-setting, and discussion of participant barriers and facilitators to exercise. Participants will also be asked to attend interviews with the study investigators to describe the aspects of the program that they enjoyed and the parts that they think could be improved upon. Overall participation in this study is anticipated to take up to 9 months. It is hoped this research will determine whether delivery of a physical activity and healthy lifestyle program via a digital platform that is supplemented with online consultations has a positive impact on the physical fitness and lifestyle choices of childhood cancer survivors. If the program is found to have a positive effect on these participants, it may be expanded to a greater number of childhood cancer survivors in the hope that it will improve their quality of life and reduce the development of chronic health conditions.

  • Oral premedication absorption during bariatric surgery

    Prophylactic antiemetic and analgesic oral premedications are frequently prescribed preoperatively to enhance recovery after laparoscopic gastric sleeve resection. However, it is unknown whether these medications transit beyond the stomach or if they remain in the stomach or sleeve resection specimen, thereby negating their pharmacological effects. The purpose of this study is to identify whether age, sex, body mass index, and diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen. Who is it for? The study will include adult patients undergoing bariatric surgery. This is a retrospective analysis of patients who underwent laparoscopic gastric sleeve resection who received premedications as part of usual anaesthesia and surgical care. Study details This study will evaluate the presence or absence of oral premedication in the stomach or sleeve resection specimens. The secondary aims will be to to evaluate whether age, sex, body mass index, or diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen. Finally, the study will evaluated the association between premedication lead time and the presence or absence of premedication in the specimen. Premedication lead time is defined as the time in minutes from when the premedication tablets were administered orally to when the gastric sleeve was resected. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the timing of premedication before bariatric surgery.

  • Does the Parkinson's Disease (PD) Warrior 10 week challenge exercise program for Parkinson's Disease improve quality of life and objective outcome measures?

    "PD Warrior" is a relatively new exercise program for people with Parkinson's Disease that is widely-used but little studied. Improvements in PD symptoms and beneficial effects on disease progression have been reported in patient surveys. Studies are yet to be undertaken confirming this. HPH-Ramsay Health Plus has a two year experience with PD Warrior and have noticed similar results. This study will assess a group of patients before and after a PD Warrior program using a number of patient outcome measures. The primary outcome will be PD-specific quality of life. Measures of motor outcome will be obtained using the Parkinson's Kinetigraph (PKG), an innovative mobile health technology device developed in Australia. This wrist-worn device is able to measure improvements in tremor, slowness of movement and mobility. We anticipate that the program will provide measurable benefits on quality of life and motor function in our patients. Study Intervention: The PD Warrior 10 week challenge exercise program. Involves attendance at a weekly one hour circuit class and a daily home exercise program. Study Outcomes: Baseline assessments prior to commencing the 10 week challenge exercise program and post completion of the program. These include quality of life (PDQ39 questionnaire), motor outcomes from the MDS- UPDRS scale Part 3 Motor examination, routinely used motor function measures - 10m walk test, 6 minute walk test, Timed Up and Go test, MiniBESTest balance test and timed hand function tests and wearing a Parkinsons Kinetigraph for 7 days pre and post the 10 week challenge exercise program.

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