Els Hostalets De Pierola, Spain

Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Volrustomig Priming Regimens Exploratory Phase II Platform Study

This is a platform, randomized, open-label, multicenter, global study. Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease. These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B. Both arms will test a volrustomig dosing in combination with chemotherapy.

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma.

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Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

A Study to Investigate the Effect on Lung Function of BDA Formulated With a New Propellant (HFO) Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma

The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma. The study duration for each participant will be approximately 14 to 15 weeks and will consist of: 1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention 2. 3 treatment periods of 4 weeks each 3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention Participants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors

Our goal is to improve control of cardiovascular (CV) disease risk factors by engaging patients experiencing health disparities in an innovative technology-based self-management intervention with linkages to health system providers. The investigators will focus on the American Heart Association's Life's Essential 8 (LE8) lifestyle factors (blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking), that when uncontrolled lead to common co-existing chronic conditions (e.g., hypertension, diabetes), morbidity, health care costs and death. Patients disproportionately affected by these risk factors (e.g., Black, Hispanic/Latino), have worse disease control with greater adverse sequelae (e.g., heart attacks and death). Self-management is an individual's role in managing chronic disease and has strong evidence of benefit. It includes self-care, a healthy lifestyle (e.g., being physically active), taking medications as prescribed and managing exacerbations of chronic condition(s). Self-management for patients experiencing disparities is enhanced when programs recognize patient context and sociocultural factors that may modify healthy behavior. Self-management can be further enriched when patients are directly supported by their health care provider. Ample evidence shows text messaging can impact self-management behaviors, with the advantage of being universally available through mobile phones. Emerging technologies utilize artificially intelligent (AI) chatbots for the delivery of text messages have the promise of improving the impact of text messaging, particularly if they integrate evidence based communication strategies, including tailoring, behavioral nudges that support intuitive decision-making, and persuasive messaging. These strategies can optimize message content beyond generic, "one size fits all" communication. It is unknown if AI chatbot text messaging with linkages to providers can improve self-management support in large diverse patient populations. Using a patient level randomized pragmatic trial in 3 health systems caring for large patient populations experiencing health disparities, the investigators will test the comparative effectiveness of theory-based, tailored and socially contextualized communications for self-management support. Patients with CV disease risk factors will be randomized to 1 of 3 automated communication approaches: 1) generic text messages; 2) interactive AI chatbot text messaging leveraging evidenced-based communication strategies with attention to patient context and sociocultural factors influencing self-management; or 3) interactive AI chatbot text messaging plus proactive pharmacist management. Our goal is to increase patient self-management autonomy, competence, and relatedness to health systems, leading to improved and sustained health behaviors, better disease control and improved patient outcomes. The primary effectiveness outcome will be an improved LE8 health score. The investigators will partner with: 1) Salud Family Health Centers, a Federally Qualified Health Center (FQHC) with 13 clinics across Colorado, 2) Denver Health and Hospital Authority, a safety net health system with 9 FQHC clinics, and 3) STRIDE Community Health Center, a FQHC with18 locations surrounding Denver county. The investigators will enroll diverse patients including: Black, Hispanic/Latino, low-income, Spanish speaking-only and rural patients with at least one LE8 factor in the poor/intermediate health category and poor adherence to CV medications. Patients will be identified using demographic, clinical and pharmacy EHR data from each health system. In Year 1 (UG3 phase), applying the Health Equity in Implementation Framework, the investigators will partner with patients, providers, community advocates and health systems stakeholders to develop the AI chatbot infrastructure and message content relevant to the patient population using an intervention mapping approach; assess how best to integrate the intervention within each health system's existing CV prevention programs; and conduct a pilot study of the intervention. In Years 2-5 (UH3 phase), the investigators will conduct a pragmatic patient randomized trial. Aim 1 (UG3; Year 1): Iteratively update the infrastructure and expand content for the AI text message chatbot with attention to social determinants of health and sociocultural contextual relevant to the target population through stakeholder engaged N-of-1 and focus group interviews and nominal group sessions. Aim 2 (UG3; Year 1): Conduct a randomized pilot to demonstrate feasibility of intervention delivery and outcomes data collection to assess preliminary effects and to refine the intervention prior to widespread implementation Aim 3 (UH3; Years 2-5): Conduct a pragmatic patient-level randomized intervention of 3 text messaging delivery strategies for self-management support of CV risk factors. Primary outcome will be change in LE8 health score. Secondary effectiveness outcomes will include individual components of the LE8 lifestyle factors, Framingham risk score, self-efficacy, medication adherence, clinical outcomes (e.g., CV related hospitalizations), and healthcare utilization. Aim 4 (UH3; Years 2-5): Evaluate the intervention using PRISM and a mixed methods approach to evaluate pragmatic clinical and implementation outcomes (reach, effectiveness, adoption, implementation, and maintenance) with an emphasis on equity and representativeness, and systematically assess contextual influences to inform sustainment and future tailoring, adaptations, and dissemination.