ANZCTR search results

There is evidence for a link between hypertension and gut dysbiosis, microbiotical profile and inflammation, and inflammation and cognition. We postulate Kyolic aged garlic extract to influence gut microbiota, and to restore gut dysbiosis in hypertensives. Our study will comprise a double-blind parallel randomised placebo-controlled trial of 3 months duration investigating the effect of Kyolic aged garlic extract on gut microbiota, inflammatory markers, and cognitive function in patients with high blood pressure.

The purpose of this study is to assess understanding of a clinical pathway for anxiety and depression screening and treatment in cancer patient. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a confirmed diagnosis of cancer. Study details Participants in this study will all receive website content (in a printed format) and a pamphlet which contain information about a clinical pathway for screening and treatment of anxiety and depression in cancer patients. Clinical pathways provide evidence-based recommendations to guide best practice and consistent care for specific patient concerns. This clinical pathway provides a pathway for screening, assessment, referral and treatment of anxiety and depression in cancer care. It was developed by a working group led by PoCoG at the University of Sydney. Focus groups and/or semi-structured interviews will then be conducted 2 weeks after participants receive the review materials. The focus groups and semi-structured interviews will collect feedback and assess participant’s understanding of clinical pathways. In this study, we will collect feedback so that we can improve the website content and pamphlet as well as determining patient understanding of a clinical pathway.

The purpose of this study is to investigate whether the Latarjet surgical procedure causes any detectable change in the strength of the biceps muscle post-operatively. If you agree to participate in the study, an appointment will be arranged for you to attend for a preoperative biceps strength test (about 15mins duration) at the University of Western Australia. This will involve taking measurements from a resistance machine similar to gym equipment which records your strength. We will also give you a short questionnaire on your shoulder function for you to complete which will take about 10-15 minutes. Your surgery and rehabilitation will not be affected. After 12 months have passed we will contact you by telephone to arrange a time for you to come in and repeat the strength test and questionnaire to see whether your biceps strength and shoulder function have changed.

We aim to investigate the impact of a telephone-based education schemes for newly diagnosed patients with glaucoma. Newly diagnosed glaucoma patients treated with drops are randomised to either the control or treatment arm. All have questionnaires administered over the telephone at the study outset and at completion, 4 weeks following the outset. The questionnaires include a Glaucoma-knowledge Questionnaire, an anxiety scale and an Eye Drop Satisfaction Questionnaire. Patients in the intervention arm will receive the education in the first week of the study period. THose in the control arm will only receive that information once the study is completed. We will measure differences in changes of scores from outset to conclusion of the study looking for differences between the intervention and control groups.

Aim? To examine whether a targeted and supervised exercise program can suppress tumour formation, growth and activity in advanced prostate cancer patients with bone metastases in Humans and examine the feasibility, safety and efficacy of combining spinal isometric training with a modular multi-modal program M3EP program. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more and have histologically confirmed adenocarcinoma of the prostate with one or more metastatic lesions in the thoracic or lumbar spine. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a 12 week exercise intervention. The exercise intervention group will receive a 3-month, supervised and individually tailored modular multi-modal exercise program (M3EP) with spinal isometric training (SIT). M3EP component of the program will be comprised of resistance, aerobic and flexibility exercises undertaken 3 times per week in an exercise clinic setting, supervised by an accredited exercise physiologist. The SIT component of the program will comprise of exercises that isometrically load deep spinal muscles. These will be performed 5 times per week (3 in clinic and 2 at home). Participants in the other group will receive usual care for the duration of the trial. Following the trial, the control group will be offered the same exercise program if the intervention is deemed to be feasible and efficacious. All participants will complete assessments at baseline and after 12 weeks in order to evaluate tumour formation and growth, muscle-bone health, adiposity, physical fitness, functional capacity, and psychosocial health.

This study will provide valuable data on the safe and efficacious use of muscle stimulation therapies currently applied by physiotherapists to patients receiving lifesaving Extra Corporeal Membrane Oxygenation (ECMO) which provides external cardiac and respiratory support for patients. Patients receiving ECMO are critically unwell and their prolonged ICU stays are associated with major loss of muscle mass and strength, and also with impaired physical function. Previously published experience from The Prince Charles Hospital (TPCH) suggests that this same patient group maybe at increased risk of foot necrosis (tissue death) either as a result of their disease process or machine techniques from the ECMO. Muscle stimulation is currently utilised by physiotherapists in TPCH ICU in an attempt to preserve the muscle mass of critically ill immobilised patients. Its effects in patients receiving ECMO have not been investigated. Changes in regional blood flow are also associated with the application of muscle stimulation.This study will demonstrate if a beneficial improvement in foot blood flow occurs as a result of muscle stimulation application which may prevent the development of foot problems in patients undergoing rescue therapy via ECMO. It will also be used to guide future research studies, and potentially therapy at this and other centres.

The primary purpose of this exercise study (in collaboration with JCU) is to investigate if regular physical activity in a group or individually improves the psychological effects whilst on hormone and radiation treatment. We aim to recruit 117 patients. The exercise program will be conducted by the exercise physiologists at the JCU clinic. Who is it for? You may be eligible to participate in this study if you have been recently diagnosed with localised prostate cancer, for which you have been scheduled to begin a combination of radiotherapy and Eligard hormone treatment. You must not have commenced Eligard hormone treatment more than one month previously. Study details: Participants enrolled in this study will be randomly allocated (by chance) to one of three groups. *The first group involves completing a group exercise program. *Participants allocated to the second group will complete an individual exercise program. *Participants allocated to the third group will not complete any exercise program, but will simply continue with their cancer treatment as normal. Participants allocated to either of the first two groups, i.e. the exercise program groups, will complete a 60 minute training session either as part of a group or on their own, three times per week for the duration of their hormone and radiotherapy treatment, or for a maximum of eight months. Exercise sessions involve aerobic/light impact activity and resistance/light impact activity. The program will alternate each week. Week 1: *2 sessions of aerobic/light impact activity *1 session of resistance/light impact activity Week 2: *1 session of aerobic/light impact activity *2 sessions of resistance/light impact activity Researchers will assess the efficacy of the exercise programs using questionnaires, s fitness test before starting the program and after finishing the program, and through a brief 15 minute interview with participants at the end of their radiation treatment. It is hoped that the findings from this trial will provide further information on the benefits of exercise during treatment for prostate cancer, and on which format of exercise is preferable and most beneficial for patients.

This study aims to determine whether using wearable technology activity monitors coupled with brief behavioural counselling and goal setting can increase physical activity and decrease sitting time amongst breast cancer survivors. Who is it for? You may be eligible to join this study if you are a post-menopausal breast cancer survivor who was diagnosed with stage I-III breast cancer, and who has completed primary treatment (ongoing hormone therapy is acceptable). Eligible participants will also engage in less than 75 minutes of moderate-vigorous physical activity per week, more than six hours of sitting each day. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a novel 12 week intervention which involves: 1) Attending an initial information and training session; 2) wearing a technology activity monitor daily to enable real-time monitoring of physical activity and sitting time; and 3) receiving five behavioural counselling and goal setting sessions via telephone. The intervention will be followed by a 12 week maintenance period. Participants in the other group will receive no intervention for the first 12 weeks. After this time they will attend an information and training session and wear the activity monitor for 12 weeks. They will not receive the behavioural counselling and goal setting sessions. All participants will complete assessments by wearing an accelerometer and inclinometer at baseline, after 12 weeks, and after 24 weeks in order to evaluate physical activity and sitting time. The proposed intervention has the potential to be an inexpensive and sustainable addition to usual care provided by clinicians, allied health professionals or via telephone-delivered cancer information and support services (such as those delivered by Cancer Councils across Australia).

This is a single-centre study using naturally acquired Plasmodium vivax (P. vivax) HMPBS02-Pv challenge inoculum to infect healthy participants in order to characterize the infectivity of the parasite isolate P. vivax HMPBS02-Pv in vivo. The goal is to determine the safety of the P. vivax blood stage malaria model following inoculation of healthy participants with P. vivax HMPBS02-Pv and the registered Chloroquine anti-malarial drug treatment. This study will be conducted in consenting and eligible male or female participants. Each participant will be inoculated on Day 0 with around 1,100 viable P. vivax-infected human erythrocytes administered intravenously. On an outpatient basis, the participants will be monitored for presence of parasites by qPCR following the challenge and then during and after the treatment, until free of parasites. During this time, participants will also be monitored for the unexpected early onset of malaria symptoms, signs or parasitological evidence of malaria. On the day designated for commencement of treatment, as determined by PCR results and/or onset of clinical symptoms of malaria infection, participants will be admitted to the study unit and confined for safety monitoring and registered Chloroquine anti-malarial treatment. Based on previous studies, it is anticipated that treatment will occur on approximately Day 8 to Day 10. Following treatment, the participants will be followed up as in-patients for 72 hours to ensure tolerance of therapy and clinical response. Once clinically well, the participants will be followed up on an out-patient basis for continued assessment of anti-malarial drug levels, and monitoring of safety, in particular liver function tests, and clearance of malaria parasites via qPCR. Follow up visits for safety assessments will be performed at specific time points until Day 28 after the malaria infection and the participants are required to be contactable and available up to 2 weeks following this end of study visit. The overall period of participation will therefore be around 4 weeks from the time malaria infection.

Iron deficiency is a common nutritional deficiency among women of childbearing age. Iron deficiency during the third-trimester of pregnancy is associated with premature birth, foetal growth restriction, stillbirth and infection. Women with iron deficiency are at risk of needing red blood cell transfusion, and having cardiovascular problems like enlarged heart or high blood pressure, reduced immune function, tiredness and depressive episodes. Iron infusion increases iron levels in the body and reduces the risk of the problems described above, but it remains unclear how the blood vessels and the heart respond to the increased iron levels. The aim of this study is to find out whether pregnant women with iron-deficiency or iron-deficiency anaemia display impaired heart and blood vessel function, and, whether this improves after iron infusion of ferric carboxymaltose. We will compare results with a group of age– and gestation-matched healthy pregnant women. We will make 2 or 3 one-hour appointments for participants to come into the Lyell McEwin Hospital: First : on the day or week before the iron infusion Second : two - four days post infusion (Third : two weeks from the first visit depending on the stage of pregnancy) 4 non-invasive tests will be performed: Laser Doppler studies — Small probes sit on the skin and measure blood flow through the very small blood vessels. We measure the way the blood vessels dilate when a drug or mild heat is applied to a small area of the skin. Arteriograph — This is a special blood pressure cuff that also measures how stiff blood vessels are. USCOM — A small ultrasonic probe rests on the skin surface of the neck and measures heart function using sound waves. Retinal photograph — We will take a photo of the blood vessels at the back of the eyes.