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Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

This research aims to provide ongoing access to treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen studies that include daratumumab. It allows all participants from daratumumab studies and those in daratumumab-containing arms of related studies, which have reached clinical cutoff for final analysis, to continue treatment. The study also collects long-term safety data from these participants. The treatments being evaluated include daratumumab, which is given either intravenously or subcutaneously, carfilzomib administered intravenously, dexamethasone given orally or intravenously, and oral medications lenalidomide and pomalidomide. Participants will continue to receive these treatments as part of this long-term extension study following their previous study treatment. During the study, participants will be monitored for safety, including tracking serious adverse events, adverse events of special interest, pregnancies, and abnormal pregnancies over a period of 3 years and 7 months. Assessments include pregnancy testing for women of childbearing potential and adherence to lifestyle restrictions. Participants must provide informed consent and will be followed closely to evaluate the long-term effects and safety of their treatment.

Researchers are evaluating whether giving XEMBIFY® every two weeks along with Standard Medical Treatment (SMT) over one year can reduce the rate of serious bacterial infections in adults with low antibody levels (hypogammaglobulinemia) who have B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma. This phase 3 clinical trial compares XEMBIFY® plus SMT to a placebo plus SMT to see which better prevents infections in this group. Participants receive either XEMBIFY® or placebo through a subcutaneous infusion pump every two weeks, combined with their regular medical treatments. The study is randomized, double-blinded, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment during the trial. Throughout the study, researchers will monitor participants for infection rates, specifically tracking major bacterial infections over about 51 weeks. Participants will have regular assessments including safety monitoring, pharmacokinetics, and infection tracking. The total study duration for each participant includes one year of treatment and observation, with careful follow-up to evaluate the treatment’s impact and safety.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with or without low-dose cyclophosphamide (CPA), in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This Phase 2b, randomized, open-label study aims to compare these treatments in patients who have previously received at least two lines of systemic therapy but whose disease has progressed. Participants will be randomly assigned to one of two groups: one group will receive DPX-Survivac, pembrolizumab, and intermittent low-dose CPA; the other group will receive DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two subcutaneous injections three weeks apart followed by up to twelve smaller doses every eight weeks. Pembrolizumab is administered by intravenous infusion every three weeks. For those in the CPA group, oral CPA is taken twice daily in a cycle of seven days on and seven days off, continuing throughout treatment. During the study, participants will be monitored for treatment response over approximately 24 months, focusing on the objective response rate in each group. Evaluations include tumor biopsies before and during treatment, laboratory tests, and disease assessments. Safety will be closely observed, and participants must have a life expectancy greater than three months to join. The study plans to enroll up to 102 subjects, with regular follow-up to track treatment effects and side effects.

Researchers are evaluating the effects of intravenous ferric carboxymaltose (FCM) compared to placebo in patients who recently experienced an acute myocardial infarction (AMI) and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to assess whether FCM impacts mortality, heart failure events, serum NT-proBNP levels, and quality of life over a follow-up period of up to 36 months. The study specifically looks at the number and timing of heart failure events, changes in heart failure biomarkers, and quality of life using the EQ-5D questionnaire.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the outcomes of a heart procedure called bifurcation PCI (percutaneous coronary intervention) using two different techniques: Culotte and Double Kiss (DK) Culotte. The study looks back at patient data collected from two high-volume cardiac centers in the Lower Silesia Region of Poland between April 2012 and January 2024. This analysis focuses on patients with coronary artery disease who had bifurcation lesions treated with two stents implanted using one of these two techniques. The treatment involves implanting two coronary stents using either the Culotte technique or the DK Culotte technique. The choice of which technique to use was made by the operator based on clinical and angiographic features. The decision to perform this two-stent approach was guided by the Heart Team's judgment or specific clinical indications such as ongoing ischemia or significant coronary artery disease suitable for PCI. All patients provided informed consent after being told about treatment options and associated risks. Participants’ data were reviewed to assess target lesion failure, which is the primary outcome measured over a five-year period after the initial hospitalization. Follow-up evaluations occur every six months after the hospitalization ends, continuing until the five-year mark. The study excludes patients who had previous PCI with coronary stents for the bifurcation lesion being studied. This retrospective analysis helps compare the safety and effectiveness of these two stenting methods in treating bifurcation lesions.