ANZCTR search results

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

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32856 results sorted by trial registration date.
  • A randomised trial of nonselective versus selective adjuvant therapy in high risk apparent stage 1 endometrial cancer.

    This study is testing the use of a surgical procedure called lymphadenectomy (or lymph gland removal) to help guide further treatment in women with endometrial (womb) cancer. Who is it for? You may be eligible to join this study if you are a woman aged 16 years or above, have histologically confirmed high risk apparent International Federation of Gynecology and Obstetrics (FIGO) stage I endometrial cancer. Study details Patients will be randomly allocated to one of two groups, Group 1 or Group 2. Patients in Group 1 will have surgery with lymph glands removed. The results of the lymph glands will be used to decide on the further treatment. Women with cancer in their lymph nodes (‘node positive’) will receive chemotherapy with or without radiotherapy. Women with no cancer in their lymph nodes (‘node negative’) will only receive an internal form of radiotherapy called brachytherapy and will not be given chemotherapy or external radiotherapy. Patients in Group 2 will have surgery with no lymph glands removed. After surgery, all women in this group will then receive chemotherapy with or without external radiotherapy. Specifics of the chemotherapy and radiotherapy will vary depending on the specific institution and individual doctor conducting the study. The purpose of this study is to find out whether there is any difference in clinical response between patients in Group 1 and those in Group 2 and to determine whether lymph gland removal improves quality of life in some patients.

  • Evaluating the impact of the Students As LifeStyle Activists (SALSA) project on dietary and physical activity of high school students

    The SALSA (Students As LifeStyle Activists) program is a school-based, peer-led initiative to improve nutritional intake and increase physical activity amongst high school students. Since 2004, the SALSA program has been provided to high schools in Western Sydney with the support of various organisations including Rooty Hill High School, Mt Druitt and Blacktown Medical Practitioner’s Associations, Primary Health Care Education and Research Unit, the University of Sydney and Western Sydney Medicare Local. The Commonwealth Department of Health has provided funding to support the implementation and evaluation of the SALSA program in high schools in 2014/15. The SALSA program is incorporated into each school’s curriculum to complement lessons taught by teachers. The program is simply described in this brief video: https://youtu.be/jiudp1few9Q This research aims to determine the extent in which the SALSA program influences positive changes in key dietary and physical activity behaviours, and intentions regarding these behvaiours, associated with a healthy lifestyle in Year 8 participants and Year 10 peer leaders. Key outcomes were: * Frequency of breakfast intake, and intention to eat breakfast daily. * Usual daily intake of fruit; and intention to eat more fruit. * Usual daily intake of vegetables; and intention to eat more vegetables. * Usual daily consumption of fruit juice and other sugary drinks (e.g. soft drinks, cordials, sports drinks and energy drinks). * Frequency of being sufficiently physically active (i.e. 60 minutes or more daily); and intention to be physically active more often. * Usual daily recreational screen use; and intention to devote less recreational time to screen activities. We hypothesised that the SALSA program would influence positive changes in the frequency of breakfast eating and other health related behaviours in Year 8 students and Year 10 Peer Leaders. In Year 8 students and Year 10 peer leaders, behaviours and behavioural intentions were measured before the SALSA program, 2 weeks after completing the program, and 3-5 months after completing the program. Ethical approval was granted in 2014 from the University of Sydney and the Department of Education (the University of Sydney no: 2014/203; SERAP no: 2014096). In late 2014, we also received approval from the Catholic Education Office to approach and recruit Catholic Schools in western Sydney to participate in the SALSA program evaluation. All high schools that implemented the SALSA program agreed to participate in the evaluation. As partners, they were responsible for distributing a letter to parents/caregivers of Peer Leaders and Year 8 students informing them of the school’s and their child’s invitation to participate in SALSA program. If parents did not wish for their child to participate in the program evaluation, a tear off slip was to be signed and returned to the school.

  • Clinical trial investigating if anti-malaria treatment DSM265 causes an allergic reaction.

    This is a clinical research study investigating the allergic potential of the experimental anti-malarial drug DSM265. Following the occurrence of cutaneous rash in one healthy subject (hereafter, subject R107) involved in a clinical investigation of the antimalarial potential of DSM265 (QP15C11/P2142), the study sponsor intends to perform cutaneous testing with DSM265. This new study has 3 parts. In Part 1, skin prick testing with various concentrations of DSM265 will be carried out in 10 healthy volunteers, to determine a non-irritant concentration for subsequent testing. In Part 2, subject R107 will be skin prick tested for DSM265 allergy, as well as for allergy to polysorbate 80, an excipient used in the preparation and in many commercially available drugs. Part 3 of the study will proceed if subject R107 skin prick testing in Part 2 is negative or inconclusive: subject R107 will be administered DSM265 p.o. and assessed for allergic symptoms.

  • Mental health and wellbeing in community sport: The Ahead of the Game program

    The overall goal of this project is to reduce the risk of mental health problems among adolescent males who participate in sports by delivering a series of mental health programs through their organised sporting club. To do this, we will embed and then test a multi-level, multi-component intervention in community sporting clubs with the primary aim of preventing the onset of mental health problems. Specifically, we aim to: (1) increase mental health literacy among adolescents and their parents; (2) increase intentions to seek and provide help for mental health problems; and (3) increase resilience. The secondary aims of this project are to prevent dropout form organised sports and to reduce the stigma associated with mental health problems among males aged 12-17 years who are associated with organised sports clubs in Australia. In combination, the programs aim to improve mental health by preventing the onset of mental health problems and encouraging early help-seeking behaviours..

  • CLinical Evaluation of the FluidVision Mongoose X Accommodating Intraocular Lens for Accommodation Restoration

    The objective of this study is to evaluate the safety and effectiveness of the investigational FluidVision (registered trademark) MX Accommodating Intraocular Lens (AIOL) in providing distance, intermediate, and near vision as compared to a trifocal IOL (Alcon PanOptix IQ), in patients undergoing bilateral cataract extraction and bilateral intraocular lens implantation.

  • Prospective randomised controlled study of pharyngo-oesophageal dilatation in Head and Neck cancer therapy-induced dysphagia: Evaluation of efficacy and safety

    The primary purpose of this trial is to evaluate the efficacy of pharyngo-oesophageal dilatation for improving ease and comfort of swallowing in patients with head and neck cancer therapy-induced swallowing difficulty. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with head and neck cancer for which surgery and chemoradiation therapy finished at least 12 months previously, which has caused ongoing difficulty swallowing. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the dilatation procedures, or to receive a single oeosophageal endoscopy during which no dilatation is provided. Participants in the dilatation group will receive a series of dilatation procedures. These involve passage of dilators to expand the calibre of the oesophagus under sedation and will occur at 2-3 weekly intervals. All participants will be followed up for 2 years following the final procedure to evaluate swallowing symptoms and satisfaction with the treatment. It is hoped that this trial will provide information on whether pharyngo-oesophageal dilatation may be an effective method for reducing symptoms of difficulties swallowing which have been caused by cancer therapies for head and neck cancer patients.

  • Use of an aid to improve communication of genetic risk information amongst families with hypertrophic cardiomyopathy.

    Genetic testing in the era of next generation sequencing technologies brings unique challenges to the genetic counselling of families. Families are confronted with large quantities of complex information for which they hold the responsibility of communicating with family members. In order to communicate genetic results or risk information the proband must have adequate understanding of the information received. Several studies indicate this may be problematic, and some individuals may not retain or understand the information presented to them. Few resources exist which aim to facilitate the process of cardiac genetic testing for patient understanding, recall and ability to communicate. Data from our research indicates cardiac genetic testing understanding, recall and ability to communicate risk to relatives may be insufficient in a subset of patients. Efforts to better communicate this information is therefore critical. We have developed a communication aid which aims to assist communication of genetic results and risk to family members. Feasibility and acceptability of the aid has been proven through a pilot study. We are seeking to determine whether a genetic counsellor- led intervention incorporating a communication aid improves knowledge, satisfaction and patient empowerment compared to current clinical practice. In addition, we aim to assess the dissemination of genetic risk information amongst family members. We are utilising a randomised controlled trial methodology. Eligible patients diagnosed with hypertrophic cardiomyopathy (with a genetic result available and ready for return) will be recruited to intervention or control. Those randomised to control will receive their result as per current clinical practice within the genetic heart disease clinic. This typically involves return of result by the genetic counsellor and cardiologist. Return of result is usually conducted after clinical cardiology review of the patient in their annual clinical review appointment.Those randomised to intervention will receive their result from a genetic counsellor with use of the communication aid. Primary and secondary outcomes will be compared between the two groups.

  • Assessing physical and/or psychological changes and personal satisfaction in cancer patient’s who attend hydrotherapy as part of their rehabilitation.

    The primary purpose of this trial is to determine cancer patient’s physical and/or psychological changes and personal satisfaction following hydrotherapy rehabilitation. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a cancer diagnosis and have been referred for rehabilitation. Study details All study participants will undergo a 6 week rehabilitation program where patients attend twice a week and have land based exercises, water based exercise and information sessions. Each exercise session is supervised and structured and tailored to suit the ability of the patient. The information sessions are face to face with the opportunity to engage with other patients and the presenter. It is hoped that this study shows that hydrotherapy is an effective and enjoyable form of rehabilitation for patients who have cancer.

  • First in human safety study of FX-322 in adults undergoing cochlear implantation.

    This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery. Approximately 13 participants will be enrolled in the study in one of three groups and will obtain either IP (investigational Product - FX-322) or placebo (in total 5 participants in group 1 - 3 active and 2 placebo - and 4 participants in group 2 and group 3 -3 active and 1 placebo). Assessed will be the diffusion of FX-322 from the middle ear, across the oval and round window membranes, and into the cochlear fluid (perilymph) as well as the tolerability of intratympanic injection of FX-322. In addition the pharmacokinetic (PK) profile of FX-322 will be assessed to determine the systemic exposure to FX-322. To assess safety by the evaluation of treatment-emergent adverse events (TEAEs); physical examination; Visual Analog Scale for pain, Tinnitus Visual Analog Scale (TVAS) and the Tinnitus Handicap Index (THI): to assess potential to cause, exacerbate or ameliorate tinnitus, and Vertigo Symptom Scale (VSS) Questionnaire and Dizziness Handicap Index (DHI): to assess effects on the vestibular system. Blood samples for determination of plasma FX-322 concentrations will be drawn pre-dose and post-dose at 1, 2, 4, and 6 hours on Day 1. Subjects will have the ~24 hour blood draw prior to discharge from the hospital. On post injection Day 3, the subjects will have their ~72 hour blood draw taken at their home. The duration of the study is 10 months.

  • A novel bundled intervention (4D’s) to improve adherence with phosphate control in people receiving haemodialysis for end stage kidney disease.

    This study aims to test the effectiveness of an innovative educational intervention ‘4D’. The intervention integrates all four methods of phosphate control, incorporating teach-back as a teaching strategy to improve adherence behaviours to phosphate control in adults receiving haemodialysis, with a target to maintain a serum phosphate level at near normal level between 0.7 – 1.6mmol/L. The anticipated study out comes will be reduced serum phosphate levels, increased knowledge on phosphate control methods, increased adherence to diet, phosphate binder medication and haemodialysis and increased self-efficacy for managing chronic disease

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