ANZCTR search results

The purpose of Study ALXN2220-ATTRCM-302 is to evaluate the long-term safety, tolerability and efficacy of ALXN2220 in adult participants with ATTR-CM treated with ALXN2220 in addition to SoC who have completed Study ALXN2220-ATTRCM-301.

This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take nerandomilast or placebo twice a day for 1 year. Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.

This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy participants. The study is divided into four parts: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Food Effect (FE), and Drug-Drug Interaction (DDI).

This study is a medium-term (6-9 years) follow-up of the health of the tissues surrounding the implant which was treated for peri-implantitis (peri-implant infection) in an already completed study with a 12 month follow-up. Patients who were treated in a randomised controlled trial with a 12 month follow-up will be invited to attend for examination of the implant and an x-ray to assess the bone levels at the implant. Participants will be asked to complete a questionnaire about their overall satisfaction following treatment.

This is an open-label, multicenter, dose-escalation Phase Ib clinical study to evaluate the safety, tolerability, efficacy, PK, and PD of FL115 injection administered subcutaneously as monotherapy in participants with advanced solid tumours. All enrolled participants will receive FL115 by subcutaneous injection. Each treatment cycle comprises 21 days, with administration once every 3 weeks (Q3W). Treatment will continue until initiation of new anti-tumour therapy, progressive disease (PD), unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, or study termination by the Sponsor, whichever occurs first.

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Mucosal and submucosal lesions of the duodenum represent a diverse group of pathologies, ranging from benign adenomas to lesions with significant malignant potential. Endoscopic resection has emerged as a minimally invasive approach; however, the success rates, recurrence patterns, and long-term outcomes remain poorly defined due to the heterogeneity of these lesions. This study aims to retrospectively evaluate the endoscopic management and long-term outcomes of patients who underwent endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla over a 15-year period. The investigators aim to assess key procedural outcomes, including complete resection rates, recurrence, complication rates, recurrence and morbidity and mortality of duodenal or ampullary malignancy. By analysing these factors, the investigators hope to better understand the role of endoscopic therapy in managing these challenging lesions and identify predictors of long-term success. This data will help guide future practice and optimize surveillance strategies for patients undergoing endoscopic resection in this complex anatomical region. Primary Objective 1. To evaluate the effectiveness of endoscopic resection of mucosal and submucosal lesions (MSML) in the duodenum and ampulla. 2. To assess the safety profile of the procedure. 3. To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy. Secondary Objectives 1. Diagnostic yield of endoscopic surveillance post endoscopic resection 2. Requirements for surgery

The goal of this clinical trial is to study the NiNA System and how it works to treat overactive bladder. Up to 290 participants will be enrolled in the study in the USA and Australia. The investigational NiNA System includes a wearable neurostimulator device ("NiNA" or "Device"), a flexible wrap to secure the Device to the calf during treatment of the saphenous nerve (SAFN), with smartphone-based control application with patient support features that allow users to control the stimulation therapy and receive reminder on days they are supposed to provide therapy ("NiNA App") or an enhanced smartphone-based control application which also has patient support features and educational multi-media content ("NiNA Care App"). The main questions the study aims to answer are: 1) How does the NiNA system compare to a common overactive bladder (OAB) medication; 2) How well does the NiNA system improve overactive bladder symptoms; and, 3) Does the NiNA system produce any unwanted side-effects. In the study half the participants randomly receive the NiNA system and the other half first receive the OAB medication and later are treated with the NiNA System. The Participants in the investigative Device arm (NiNA) will: Provide NiNA system treatments very day for 30 minutes during a 28 day induction/restore period. This is followed by maintenance treatments (30 minutes, 3-times a week) until 12 weeks, when the primary endpoint data are measured. Participants continue maintenance (30 minutes, 3-times a week) for the remaining 52 weeks of the study. Participants in the OAB medication arm will: Take a capsule every day (tolterodine tartrate extended release (ER) 4 mg) for twelve weeks. At 12 weeks, OAB medication arm Participants will stop taking the OAB medication and cross-over to treatment with the NiNA system. One-third of the cross-over Participants will be use a phone-based software application that allows them to control the neurostimulator and receive reminders on days the are scheduled to provide their therapy (NiNA App) and the other two-thirds of the cross-over Participants will use a phone based software application that also contains educational videos that reinforce the therapy (NiNA Care App). Assignment to each arm is random. The study will measure primary and secondary endpoints completely remotely using digital questionnaires that are presented to Participants on a specialized software application installed on their phones ("Study App"): Changes in OAB symptoms at a defined set of time points using the following instruments: 1. Bladder diary (3-day, consecutive); 2. Self-administered and validated Quality-of-Life questionnaires (see Effectiveness Assessments); 3. Additional assessments of participant satisfaction and preferences will be obtained using participant study surveys and questionnaires at defined study time points.

Patients with refractory autoimmune diseases often have limited treatment options and ongoing disease activity despite standard therapies. CRT-402 is an in vivo Cluster of differentiation 19 (CD19)-targeted CAR-T cell therapy designed to deplete CD19-positive B cells and promote immune system reset. This study evaluates the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of CRT-402 in participants with active refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).