ANZCTR search results

Prior Phase 1 and Phase 2 clinical studies have administered EMA401 in a capsule formation. This study in normal healthy adults will inform the selection of an oral tablet dosage form of EMA401 for future Phase 2/3 clinical trials.

The primary aim for this study is to quantitative and qualtitative feedback regarding the feasibility and acceptability of a remotely delivered self-management course designed to increase physical activity, myMoves, to community-dwelling adults living in the Australian community following an Acquired Brain Injury.

The T4ADS study will investigate whether androgen deficiency-like symptoms, such as decreased sense of well-being, energy, libido, motivation, improve following 6 weeks of testosterone (T) gel application significantly more than during 6 weeks of placebo gel treatment. The study will run at the Department of Andrology, CRGH and will aim to recruit 40 men with possible androgen deficiency-like symptoms from the local community. Men 40 and over will be invited to join the study if they or their own doctor believe they have androgen deficiency. Volunteers interested in participation will be screened for eligibility by medical history, physical examination and blood tests. Eligible and consenting participants will be randomised at enrolment to receive either T or placebo gel as their first 6 week treatment and the alternative gel in the second treatment period. The third 6 week treatment period will let the men chose which gel they prefer to use. Study visits will be over a total of 27 weeks. It is hoped that androgen deficiency-like symptoms improve significantly following 6 weeks of T gel application than during 6 weeks of placebo gel treatment. We would also like to determine whether pre-treatment blood T levels predict a superior response to T compared to placebo and whether the participants preferred treatment, either T or placebo is reproducible when the preferred treatment remains blinded.

Ageing is associated with a physiological reduction of appetite and energy intake, which has been called the “anorexia of ageing”. Dietary supplementation with liquid protein preparations is now used frequently to increase energy and protein intake in older adults in both institutionalized and community-dwelling populations. Although the latter would appear a logical approach, evidence for success of increased energy intake in older individuals is limited. It is well established that the ingestion of nutrients induce a number of changes in gastrointestinal (GI) function, which are associated with the modulation of appetite and energy intake. These changes include the slowing of gastric emptying, which sustains gastric distension and is associated with proximal gastric relaxation. Urgent investigation is warranted to determine the optimal load of protein that can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite. The study aims to characterise in healthy older individuals, the effect of timing of protein preloads on energy intake, appetite, plasma concentrations of hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose, and studies the relationship between the suppression of appetite and energy intake by protein.

Study hypothesis: Current clinical management of OSA is to use continuous positive airways pressure (CPAP) as a first-line treatment, and CPAP is approved in Australia for this purpose. Some people find CPAP difficult to tolerate and sleep with, so other treatments may be useful. Oxygen therapy is one form of treatment that could potentially treat OSA patients with unstable breathing control as the key factor underlying OSA. Primary purpose: The aim of this study is to test if oxygen therapy is an effective and acceptable alternative treatment to CPAP for patients with unstable breathing control underlying their OSA.

The primary purpose of this trial is to test whether Cognitive Behaviour Therapy for insomnia (CBT-I) is effective for older adults with comorbid insomnia and depression, and test whether an advanced form of Cognitive Behaviour Therapy for insomnia and depression (CBT-I-D) produces better sleep and mood outcomes for older adults. It is expected that the advanced CBT-I-D group will produce better overall outcomes compared to the CBT-I group and control group.

The main objective is to determine the effectiveness of a method of assisting classroom teachers to conduct physical education and sport in primary schools. We are testing the Physical Literacy (PL) Facilitator scheme which proposes to introduce a trained PE teacher into a group of 8 schools. Roles of the Physical Literacy Facilitator include: 1) In-class professional development for the generalist classroom teacher. He or she provides teachers with new and innovative classroom teacher-friendly lesson plans, designed to be consistent with the new Physical Education National Curriculum guidelines. 2) Promote cooperation between school sport and community sport/active recreation groups by introducing children and parents to sporting groups and other clubs and physical activities, including after-school programs 3) Education of junior sport coach through local media and discussion groups. 4) Identify children with special barriers to developing sufficient physical literacy (e.g. obesity, postural problems, and motor coordination disorders) and contact parents to discuss options to overcome the barriers. 5) Encourage and facilitate engagement (and increased physical activity) in the school environment (at recesses, before and after school)

Periodontitis is a chronic infection, which is mainly associated with Gram-negative bacteria. The aim of the systematic periodontal therapy is to reduce the number of periodontal pathogens to avoid a further progression of the disease, thus to avoid further attachment/bone loss. Systematic periodontal therapy involves, after completion of the initial hygiene phase, debridement of the exposed root surfaces by means of scaling and root planning (SRP). However, some periodontal pathogens have shown to be very resistant to the conventional treatment of periodontitis: SRP and/or surgical periodontal therapy. Even the additional use of systemic and/or local antibiotics has not been able to completely eliminate the pathogens or to maintain periodontal health over a longer period of time so far. In recent times a novel approach, the so called Air Polishing (Ap) has been developed for the removal of subgingival biolfim during SPT with the use a fine powder delivered via a commercially available injection abrasive water jet. Due to the small particle sizes of the powder the damage to the root surfaces compared to sonic, piezoelectric ultrasonic and magnetoconstrictive ultrasonics, is considerably lower. The aim of this study is to investigate whether an adjunct use of a recently introduced Erythritol Powder (Ep) could further improve the clinical and/or microbiological parameters in patients with a mild or moderate type of chronic periodontitis who already received initial therapy (SRP) but are still showing probing pocket depths (PPD) of greater than, or equal to 5mm including bleeding on probing (BOP).

This study will evaluate strategies to implement evidence-based guidelines for screening, assessment and management of cancer pain in adult outpatients presenting at oncology and palliative care services. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with any cancer and are attending a participating cancer centre as an outpatient. Study details All centres will start in the control arm and transition to intervention arm, but the order in which they transition will be allocated randomly (i.e. by chance). The control arm will receive screening for cancer pain with feedback to medical team to inform treatment and care according to local practice. The intervention includes the addition of strategies to implement evidence-based guidelines for screening, assessment and management of cancer pain. Strategies will include: An audit tool to enable centres to monitor how well they are implementing core standards of cancer pain assessment and management; a toolkit for identifying barriers and facilitators to practice change and implementing strategies to overcome these; QStream online health professional education to test and consolidate knowledge of cancer pain assessment and management; patient-held resources to ensure management remains centred on individual patient needs, support patient-health professional communication and coordination and help patients advocate for evidence-based, person-centred care. The study will compare a time before the strategies are introduced with the time when they are being used to see if there is a difference in the probability of a clinically important reduction in pain for patients with moderate-severe pain. It will also test the effects of the strategies on patient quality of life and empowerment, carer experience, and cost-effectiveness of care.

The primary purpose of this study is to evaluate whether acute supplementation with either of two nutraceutical combination formulas (ErgGo Mom and ErgGo POP), relative to placebo, reduces self-rated mental fatigue associated with performing cognitively demanding tasks.