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Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies
Expand descriptionThis study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.
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Improving Survivorship for Critically Ill Patients Aged 65 and Over
Expand descriptionIMPROVE-65 is a randomised control trial designed specifically for people aged over 65 who have survived critical illness. It aims to support patients and general practitioners by providing timely, personalised information to help them work together to make informed goals and decisions about their care after hospital discharge. The aim of the study is to improve recovery and avoid preventable hospital readmissions.
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A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
Expand descriptionThis study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). Each eligible participant will receive standard of care (SOC) plus ROC-101 for a 24-week treatment period, followed by a long-term extension period of the study through the end of the program or marketing approval/authorization.
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A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
Expand descriptionThis is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
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A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
Expand descriptionThe purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
Expand descriptionThe purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
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ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Expand descriptionThis is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
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Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.
Expand descriptionThis study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks. Adults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation. Participants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care. Participant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.
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A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
Expand descriptionThe primary objective of the study is to evaluate the safety and tolerability of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.
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Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Expand descriptionParticipants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions. The goal of this clinical investigation is * To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention * To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device