ANZCTR search results

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

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32187 results sorted by trial registration date.
  • A Prospective Study to Assess Primary Anatomical Shoulder Arthroplasty Outcomes in Patients Diagnosed with Glenohumeral Arthritis

    This is a study involving multiple hospitals in Australia and is collecting data prospectively. Its aim is to assess patients presenting glenohumeral arthritis who are undergoing a primary anatomical total shoulder arthroplasty procedure. The performance of the Affinis Glenoid vitamys uncemented in anatomical total shoulder arthroplasty is assessed through: • Survivorship (rates of revision) • Patient mortality rates, • Range of Motion analysis, • Complications • Evaluation of x rays • Patient reported outcome Measurements (PROMs)

  • Plant-based and Animal-based Protein Diets on Muscle Growth and Functional Health in Overweight Elderly - Pilot (Phase 1)

    This study includes a pilot study (phase 1), designed to assess the equipment at Deakin, using D2O enrichment and LC-MS/MS and GC-MS techniques, to detect fractional protein synthesis rate (FSR) comparable to existing literature (FSR ~0.0542%·h-1). The outcomes from the pilot study will inform a larger RCT in ralation to the dosing protocol and analysis for the RCT, as well as the dietary counselling and assembly. This is done to ensure the reliability and success of the RCT, and ensuring the methodology is effective for the intended purpose. Should the pilot show insufficient detection of MPS using the current dosing protocol, adjustments will be made before proceeding with the RCT. (D. J. Wilkinson et al., 2015).

  • Feasibility of Sonas Programme in Australian Context: A Pilot Randomised Controlled Trial

    The Sonas Programme is a structured, multisensory group intervention designed to enhance communication and well-being in people with dementia and/or people with communication difficulties. It includes activities such as music, singing, touch, and sensory stimulation delivered in a supportive environment. This study aims to evaluate the feasibility of Sonas Programme in aged care settings in Australia.

  • SCORE-CUT DCB Trial: A Randomised Comparison of Scoring, Cutting, and Non-Compliant Balloon Lesion Preparation Strategies for Drug-Coated Balloon Angioplasty

    Drug-coated balloon (DCB) angioplasty is increasingly recognised as a viable alternative to drug-eluting stents (DES) for selected de novo coronary artery lesions, particularly in scenarios where stent implantation is undesirable. The success of DCB therapy is highly dependent on optimal lesion preparation.. The most commonly used lesion preparation strategies include non-compliant balloons, scoring balloons, and cutting balloons, but head-to-head comparative data in native coronary lesions are lacking. The primary aim of the SCORE-CUT DCB Trial is to determine the optimal lesion preparation strategy prior to drug-coated balloon (DCB) angioplasty in de novo coronary artery lesions. The trial seeks to compare the final minimal lumen area (MLA), as assessed by intravascular ultrasound (IVUS), among three commonly used preparation techniques: scoring balloon, cutting balloon, and non-compliant (NC) balloon.

  • Preparing for motherhood: a one-day group antenatal workshop to support postpartum adjustment for first-time mothers.

    This feasibility and acceptability pilot evaluates a one-day antenatal group workshop designed to mentally prepare first time mothers for the early postpartum months, and support adjustment during this time. The workshop covers practical coping skills, mindfulness and acceptance strategies, self-compassion, and how to build confidence in parenting and bonding with baby. In their third trimesters of pregnancy, participants will be randomly allocated to either the workshop group or the no workshop group (care as usual). We plan to assess whether the study is feasible and acceptable to participants. We will also preliminarily explore whether increasing psychological flexibility, self-compassion, and parental self-efficacy helps to support better postpartum adjustment - that is, less distress and better coping. This will be measured using brief online questionnaires (2 during pregnancy and 2 postpartum at approximately 6 and 12 weeks post birth). We hypothesise that the workshop will be feasible to deliver, acceptable to participants, and indicate effect size trends that show preliminary signs of improving the adjustment to motherhood when compared to usual care.

  • The Relax Study: investigation of adjuvant Botox injection in the surgical repair of complicated perianal fistula disease

    The Relax Study will test whether Botox injection into the anal sphinceters and pelvic floor during standard surgery can improve healing and symptoms for people with complex perianal fistula. Botox briefly relaxes the anal muscles, which may support recovery. Participants will receive surgery with or without Botox and will report on their symptoms afterward. We hypothesize that Botox will lead to better symptom improvement and healing at three months.

  • A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy in Participants with Relapsed/Refractory Autoimmune Neurologic Diseases

    KITE-363 is an exploratory treatment for autoimmune neurological diseases such as multiple sclerosis, myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. KITE-363 utilizes a patient's own T-cells, which are genetically modified to target and eliminate pathogenic, harmful cells, KITE-363 aims to reduce the effects of autoimmune neurologic diseases

  • Research Evaluation of an Exosome-based Nutraceutical for Vitality and Immune function Given ORally: RE-ENVIGOR study

    Ageing is associated with declines in cognition, immune competence, and physiological performance, which contribute to reduced health span and quality of life. CX-50 may contain bioactive compounds (exosomes) hypothesised to modulate immune and metabolic pathways relevant to ageing. Exosomes represent a promising target for health span extension given their favourable safety profile and accessibility. This Phase 1 trial is being conducted as part of the XPRIZE Healthspan Semi-Finals to assess safety and feasibility in a controlled environment, in preparation for the competition Finals.

  • The MENOCOG Trial: Feasibility, acceptability, and safety of creatine monohydrate supplementation for cognitive function and mood in postmenopausal females with subjective cognitive decline: a randomised, double-blind, placebo-controlled, parallel-group trial

    In Australia, dementia is the leading cause of death in females over 65 years of age. The menopause transition is an important physiological event unique to women that can increase susceptibility to cognitive decline and risk of dementia. During menopause, the ability for the brain to produce cellular energy to support healthy function is reduced. Emerging evidence suggests creatine monohydrate can support brain energy production and improve cognitive function and mood. The current study will evaluate the feasibility, acceptability, and safety of oral creatine monohydrate for cognitive function and mood in postmenopausal females with SCD using a 12-week randomised, double-blind, placebo-controlled, parallel group trial.

  • Safety and Efficacy of SL-28 in Patients With Advanced Solid Tumours ( Phase 1/2)

    This study aims to assess the anti-tumour activity, safety, and interactions of single-agent SL-28 as an anti-cancer treatment in patients with a diverse array of solid tumours. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced solid tumor, including head and neck cancer, small-cell lung cancer, non-small cell lung cancer; mesothelioma; oesophageal cancer, gastric cancer, liver cancer, colorectal cancer, pancreatic cancer, bladder cancer, kidney cancer, prostate cancer, ovarian cancer, endometrial cancer, breast cancer or skin cancer (melanoma) that is locally advanced, metastatic or unable to be surgically removed. Patients will also be assessed by a study doctor to ensure that they are well enough to participate in the trial before they will be offered enrolment into the study. Study details All participants who choose to enroll in this study will receive 12 weeks of SL-28 treatment, administered on a 5-days-on, 2-days-off schedule. The first group of participants to receive SL-28 will be monitored for 12 weeks before a second group may be administered a higher dose of SL-28. Up to three cohorts will be enrolled to determine the highest safe and effective dose that does not cause severe side effects in patients. It is hoped this study will show that SL-28 is safe to deliver to patients with solid tumour cancers, and determine the highest dose of SL-28 that cancer patients can safely receive.

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