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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting two related studies called RADICAL PC1 and RADICAL PC2 focused on men diagnosed with prostate cancer. RADICAL PC1 follows men within one year of their prostate cancer diagnosis or who have recently started androgen deprivation therapy (ADT). The goal is to understand factors linked to developing cardiovascular disease in these men, especially related to ADT. RADICAL PC2 is a randomized controlled trial within RADICAL PC1 that tests a systematic approach to improving heart health and lifestyle risk factors in this population. The treatments studied include behavioral advice on healthy nutrition, exercise including strength and resistance training, and smoking cessation support if needed. Drug treatments include prescriptions of low to moderate dose statins and ACE inhibitors or angiotensin receptor blockers for controlling blood pressure above 130 mmHg. The intervention targets men newly diagnosed or recently starting ADT, and treatment is personalized based on cardiovascular risk. Participants engage in assessments to monitor heart-related outcomes such as death, heart attacks, strokes, heart failure, or arterial revascularization over 3 to 5 years. The study tracks cardiovascular health and lifestyle factors throughout this period to evaluate the effectiveness of the interventions. Safety and progress are closely monitored to understand impacts on long-term outcomes in men with prostate cancer undergoing ADT.
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
Researchers are investigating a treatment approach for patients hospitalized with community-acquired pneumonia (CAP), a condition with high rates of illness and death. This phase 3 trial compares therapeutic-dose heparin versus usual care pharmacological thromboprophylaxis to see if it improves patient outcomes. The study focuses on preventing complications caused by blood clots and inflammation that can worsen respiratory and organ function in CAP patients. Previous findings in COVID-19 pneumonia suggest heparin might reduce disease progression and mortality, but its effects in non-COVID-19 CAP are unknown. Participants will receive either therapeutic-dose heparin, preferably a low molecular weight heparin (LMWH) like enoxaparin, dalteparin, or tinzaparin, dosed by patient weight unless contraindicated. Intravenous unfractionated heparin (UFH) may be used instead, especially for those with kidney issues, with dosing adjusted to specific blood clotting targets. The trial is open-label and randomized, with adaptive rules to monitor progress. Usual care pharmacological thromboprophylaxis is the comparator. Treatment and monitoring occur during hospital admission, anticipated to last at least 72 hours after randomization. During the study, patients are assessed for survival at 30 days and monitored for complications related to CAP. Researchers collect clinical data including oxygen use, laboratory tests, and adverse events, tracking safety and effectiveness. The study excludes patients with active COVID-19, recent bleeding, contraindications to anticoagulation, or those receiving critical care interventions. Overall participation depends on hospital stay length and clinical status, with follow-up to evaluate the primary outcome of survival within a month.
Actively Recruiting
Researchers are evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in adults hospitalized with severe community-acquired pneumonia (sCAP) who require invasive mechanical ventilation. This phase III, randomized, placebo-controlled, double-blind, multi-center trial aims to compare trimodulin plus standard care against placebo plus standard care. The study also includes substudies to understand the pharmacokinetics and pharmacodynamics of trimodulin. Participants will be randomly assigned to receive either trimodulin or placebo via intravenous infusion once daily for five consecutive days alongside standard care. After the treatment phase, patients will be followed for up to 23 days, with an end-of-follow-up visit or telephone call on day 29. For those still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a final visit or call on day 91. During the study, participants will undergo various assessments including monitoring of mortality rates up to day 29, clinical evaluations, and safety monitoring. Researchers will collect data on inflammation markers and other health parameters. Follow-up contacts and visits will ensure ongoing evaluation of patient status and adverse events throughout the study period, which may last up to 91 days or longer depending on hospital discharge timing.
Actively Recruiting
Researchers are evaluating the effects of adding inclisiran to usual care compared to usual care alone on lowering LDL cholesterol in patients admitted to the hospital after an acute cardiovascular event such as a heart attack, ischemic stroke, or urgent coronary revascularization. This phase 4, multi-country, open-label clinical trial focuses on patients who have been stabilized in the hospital following these acute events. The study aims to understand how this combination impacts LDL cholesterol levels, patient-reported outcomes, and healthcare resource use in a real-world hospital setting. Participants are randomly assigned in a 1:1 ratio to receive either inclisiran plus usual care or usual care alone. Inclisiran is given as a subcutaneous injection on day 1, day 90, and day 270. Usual care includes treatments approved in the patient's country after the acute event, which may include educational interventions following local guidelines. The study tracks the participants over a period of approximately 330 days, including initial treatment and follow-up visits. During the study, participants undergo assessments of LDL cholesterol levels at baseline and on day 330 to measure changes. Researchers also evaluate patient-reported outcomes and monitor healthcare resource use. The study ensures participants are stable before randomization and follows them through their hospital stay and post-discharge period. Completion of the study is marked by the final visit and associated evaluations on day 330, allowing for a comprehensive evaluation of the treatments' impact over nearly a year.
Actively Recruiting
Researchers are studying dental implant systems to assess their safety and effectiveness in patients who have lost part or all of their teeth. This prospective observational study focuses on implants used in real-world clinical practice, targeting adults aged 18 to 70 with good overall health and healthy areas where teeth are missing. The study aims to better understand how well these implants perform, considering that injuries to facial bones like the zygomatic complex are common and dental implants can improve quality of life by restoring chewing, speech, and self-esteem. The study will observe patients who receive one of several types of DSP dental implant systems, including Standard Internal Hexagon, Large Internal Hexagon, Flexcone, Mini Flexcone, and Morse Internal Hexagon implants. No specific surgical procedures are mandated by the study; instead, it records data from routine oral surgeries under local anesthesia. The implants will be monitored over time, with no additional interventions beyond usual care. Participants will be followed for one year with scheduled visits at baseline, 90, 180, and 360 days after implant placement to assess outcomes such as implant success and osseointegration. Data collection will use electronic systems to track implant performance, safety, and any adverse events. The study expects to complete data gathering within 24 months after the first patient is enrolled, aiming to provide valuable information on the implant systems' safety and effectiveness in everyday clinical settings.