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Digital Health Technology for People With Mitochondrial Disease
Expand descriptionAbstract: A lack of exercise combined with low levels of activity is prominent in people with Mitochondrial Disease (MD). Unfortunately, access to health professionals such as physiotherapists with experience in MD is difficult, especially in remote areas. The use of digital health technology (DHT) may be a feasible and acceptable way to remove access barriers while increasing participant compliance and self-efficacy with exercise. Given that the implementation of DHT to improve exercise compliance is scalable and inexpensive, it's important to test this intervention clinically. Objective: To determine the feasibility and acceptability of a structured home exercise program, supported by DHT, in people with MD. Methodology: Ten to 15 participants from the MD clinic at Neuroscience Research Australia will be recruited for this study. All participants will be remotely monitored for 8-weeks, provided with a customised, structured home exercise program and activity monitor smart watch. Training volume will increase gradually. Participants will receive weekly, individualised emails supporting their exercise program, weekly telehealth coaching sessions and pre-programmed smart watch movement reminders. Physical performance measures will be taken at week 0, pre-intervention and week 9, post-intervention. Questionnaires on fatigue, quality of life and acceptability of the program will also be administered. Results: Feasibility will be determined from the percentage of participants who enrol in the study from the eligible pool, percentage of dropouts over the study duration, and the percentage who adhere to the exercise program (defined as completing =75% of the regimen). Acceptability outcomes will be extracted from post-program questionnaires. Descriptive statistics of outcome measures (means and standard deviations) and any changes from pre to post will also be calculated. Conclusion: If shown to be feasible and acceptable, this intervention has the potential to deliver a significant impact on the lives of individuals with MD and the wider MD community.
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A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC)
Expand descriptionThe main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the saline + nivolumab arm.
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An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
Expand descriptionThe purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.
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A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Expand descriptionThis study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.
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A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Expand descriptionThis is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.
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A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
Expand descriptionThe purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
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Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus
Expand descriptionThe study is designed to evaluate the preliminary efficacy, safety, population PK profile, and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus.
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A Phase ? Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Expand descriptionThis is a double-blind, randomized, multiregion, comparative phase ? clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
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EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
Expand descriptionThis study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart disease. This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. Participants continue taking ACEi or ARB throughout the study if such treatments are indicated. In the second part, participants are divided into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 4 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.
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Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
Expand descriptionThe objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture. The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.