There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to assess the safety, pharmacokinetics and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.
Ten patients with motor neurone disease (MND, also known as amyotrophic lateral sclerosis or ALS) will be successively enrolled to one of two dose levels of IC14 (human chimeric monoclonal anti-CD14) intravenously for four doses. Patients must be within 3 years of MND diagnosis and have adequate respiratory function. Safety, tolerability, immunogenicity, and PK/PD will be measured. To evaluate feasibility of the endpoints, additional endpoints of ALSFRS-R, respiratory function tests, disease biomarkers and patient-reported outcomes will be measured.
This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.
The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
Between 45-73% of people who have had a stroke fall over in the months and years following their stroke. Falls not only lead to injuries such as broken hips, but they may also lead to fear of falling. As a consequence people can get fearful to walk, keep up their household tasks and their social activities such as visiting friends and family. Research has shown that exercises for strength and balance can help both older people and patients after stroke to get fitter and healthier and help to prevent them from having a fall. People also have less falls if they have learned about falls facts and home safety precautions. Research has further suggested that people have less fear of falling and less injuries from a fall if they have learned how to fall ('safe landing' strategies). Based on these research findings the researchers have developed a new falls prevention programme called the Fall Monty Activity Programme (FallMAP). This programme aims to aid in functional recovery and reduce falls by combining a mix of activities such as falls education, strength and balance exercises, and activities that teach people how to get up from the floor and how to fall safely. Especially because people with residual impairments following a stroke have an increased risk of a fall, the feasibility of this programme will be tested in a small group of people after stroke first. This study is a first step in establishing whether the different components of the FallMAP are acceptable and practical for both patients after stroke and staff who deliver the program. In particular, it is important to evaluate if it is feasible to provide the seven combined components as one comprehensive programme. Secondly, the question whether participating in the programme can positively influence the participants' fear of falling, quality of life, leg strength, balance and mobility will be explored. If this feasibility study suggests the programme can work in the clinical setting, then a definitive randomised controlled trial will be proposed in order to look at whether the full programme is effective at reducing falls in patients after stroke.
To evaluate the effectiveness of 4 g Swisse High Strength Deep Sea Krill Oil (Superba BOOST) daily on pain reduction in adults with mild to moderate osteoarthritis of the knee compared to placebo over a 6 month period. This is a multicentre, randomised, double-blind, placebo-controlled parallel-arm study. Applicants will be eligible to participate if they have mild to moderate OA of the knee. Diagnosis of OA of the knee will be made according to clinical diagnosis, using the American College of Rheumatology (ACR) Criteria for the classification of Idiopathic OA of the Knee and the Kellgren-Lawrence grading scale. In addition, eligible applicants will have been experiencing knee pain on at least 4 days per week, for at least 3 months and they will report knee pain between 4 and 8 cm (inclusive) on a visual analogue scale (VAS) for the 7 days prior to Day 1 of the trial (Baseline). Severity of OA of the knee will be assessed based on X-ray performed at the Screening Visit using the Kellgren-Lawrence (KL) radiographic criteria, and participants with severe radiographic knee OA (KL joint space narrowing (JSN) above grade 3) will be excluded. Applicants will attend a screening visit following pre-screening assessments to assess their general health and eligibility for inclusion into the study. On Day 1 eligible participants will be randomly allocated to receive one of two study treatments. Participants will take the assigned treatments daily for six months. Participants will return to the clinic at 3 months and 6 months for study assessments. Participants will complete an online survey at 1, 2, 4 and 5 months to assess protocol compliance, adverse events and use of concomitant medications. Any queries from the survey will be followed up by phone call. A final participant online survey and phone call (if needed) will be conducted 28 days after the 6 month visit for a final safety assessment.
The aim of the present study is to evaluate chronic supplementation with Swisse Ultiboost Memory + Focus over a 12 week period on memory in individuals with optimal and sub-optimal nutrient profiles.
This is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative sponsor and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by chronic pacreatitis (CP) and/or distal pancreatectomy. The new medication is called MS1819 Spray Dried (MS1819-SD) which is a lipase produced by the LIP2 gene of Yarrowia lipolytica using recombinant DNA technology. The primary purpose of this study is to investigate the safety of escalating doses of study drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss. The design of the study is open-label, meaning that all eligible participants will receive the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods. The total duration of the MS1819-SD treatment phase is of 48-60 days, The total duration of patient participation in the study is of 74-93 days. Approximately twelve patients will be enrolled in this study.
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG).