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Found 32 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Age: 18Years +All GendersPhase 3
1264 locations
A

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.

Age: 18Years +All GendersPhase 3
639 locations
A

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.

Age: 18Years +All GendersPhase 3
653 locations
A

Actively Recruiting

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Age: 18Years +All GendersPhase 3
970 locations
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Actively Recruiting

Researchers are evaluating clay therapy as a complementary approach for people with schizophrenia, a chronic mental illness that can cause symptoms like delusions, hallucinations, and functional difficulties. Schizophrenia often involves relapses and affects social and individual functioning. While medication is a mainstay of treatment, this study seeks to understand how clay therapy, a type of art therapy, might support functional recovery and improve social and individual performance in patients who are already receiving pharmacological treatment. Participants in the study will receive clay therapy, which helps express emotions, bring unconscious feelings to the surface, and aids verbal communication and symbolization. The therapy is being studied for its potential to enhance treatment compliance and disease awareness. This intervention is given alongside the usual medication as part of the treatment plan. The study focuses on patients who are in remission and have been regularly attending a community mental health center. During the 12-week study, researchers will assess participants using a Functional Recovery Scale designed for schizophrenia patients. Participants will be monitored for changes in functional abilities and social behavior. The study includes evaluations of individual and social performance to determine the impact of clay therapy on daily functioning. The total duration of participation covers the therapy period and follow-up assessments to measure outcomes.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are investigating the use of drug-coated balloons (DCBs) in treating various types of coronary artery disease (CAD), including stable and acute coronary conditions. The study evaluates the procedural success and both short- and long-term outcomes of DCB use in multiple clinical scenarios such as in-stent restenosis, de novo lesions, bifurcation lesions, small and large vessels, and chronic total occlusions. This multicenter observational registry in Türkiye aims to provide real-world evidence on the safety, feasibility, and clinical results of DCB angioplasty beyond conventional uses. Patients undergoing percutaneous coronary intervention (PCI) with a DCB-based strategy, either alone or combined with bailout stenting, are included. Detailed clinical, laboratory, angiographic, and procedural data are collected, including lesion preparation methods, use of intravascular imaging, and DCB characteristics like type and inflation protocol. The study covers a broad range of lesion types and clinical presentations, aiming to assess procedural success and the need for additional stenting. Participants are followed to monitor outcomes such as death, target lesion and vessel revascularization, myocardial infarction, stent thrombosis when applicable, and overall cardiovascular events over 12 months. Data on major adverse cardiovascular events (MACE) and mortality are recorded to understand long-term safety and effectiveness. The study also explores factors influencing success and failure, intending to guide future trials comparing DCBs with new-generation drug-eluting stents.

Age: 18Years +All Genders
5 locations
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Actively Recruiting

Researchers are exploring how breathing and aerobic exercises affect certain biomarkers linked to neuron development and inflammation in adults diagnosed with major depression. The study focuses on changes in growth factors such as IGF-1, FGF2, and EGF, as well as inflammatory markers like TNF-b1, IL-6, and IL-1, along with oxidative stress indicators including TAS, TOS, MDA, and F2-isoprostane. These biomarkers are believed to play a role in the underlying mechanisms of depression. Participants in the experimental group perform daily breathing exercises for three weeks. These exercises involve focusing on abdominal breathing with specific hand placement to ensure proper technique, progressing from lying down in the first week to sitting in the second week and standing in the third week. Additionally, participants engage in aerobic walking exercises at 80% intensity for at least 30 minutes, three days a week, over the same three-week period to help their bodies adapt and maintain the practice. During the study, researchers measure changes in oxidative stress biomarkers and proinflammatory cytokines from enrollment until the end of the three-week treatment. Participants are monitored for adherence to the exercise routines, and the impact on neuroprotective and inflammatory biomarkers is assessed. The total participation duration for each individual is three weeks, during which the study collects relevant biological samples and data to evaluate the effects of the interventions.

Age: 18Years - 40YearsAll GendersPhase Not Applicable
1 location
E

Actively Recruiting

Neonatal jaundice, a common condition causing yellowing of the skin and eyes due to high bilirubin levels, affects many newborns within their first week of life. Phototherapy is the standard treatment to reduce bilirubin levels but can cause side effects such as skin rashes, dehydration, and changes in body temperature. This research aims to evaluate how bathing influences physiological parameters, skin condition, bilirubin levels, and comfort in infants receiving phototherapy. In this study, infants in the experimental group will receive a bathtub bath before starting phototherapy treatment. Researchers will monitor and compare these infants' heart rate, respiratory rate, body temperature, oxygen saturation, skin moisture, skin condition, bilirubin levels, and comfort at multiple time points including before bathing, and at 30 minutes, 60 minutes, and 6 hours after treatment or bathing. Bilirubin levels will also be checked again 24 hours after phototherapy begins. Participants will be carefully observed using standardized forms to record vital signs and skin assessments. Comfort levels will be measured multiple times during the study to understand the effect of bathing. This detailed monitoring aims to capture changes in infants' physiological status and well-being, helping to understand if bathing is beneficial during phototherapy. The study includes infants up to about 2 days old and involves close follow-up over the first day of hospitalization.

Age: 1Day - 28DaysAll GendersPhase Not Applicable
1 location
E

Actively Recruiting

This research aims to assess how motor imagery training affects pain, functionality, proprioception, and fear of movement (kinesiophobia) in adults with partial rotator cuff tears. Rotator cuff tears are a common shoulder problem involving muscles that stabilize the joint, often caused by injury, aging, or repetitive use. Symptoms include shoulder pain during overhead movements, limited motion, muscle weakness, and loss of function. Treatment varies by tear size and symptoms, including conservative and surgical options. Motor imagery involves mentally simulating movements and may improve motor skills and treatment outcomes when combined with physiotherapy. Participants will be randomly assigned to either a traditional physiotherapy group, receiving hotpack, TENS, and ultrasound treatments, or a motor imagery training group practicing kinesthetic and visual motor imagery. Both groups will undergo 20 sessions over 4 weeks with a physiotherapist, five days a week. The treatment plan is personalized by a specialist physical therapy physician. Participants will be evaluated before treatment, at the end of the 4-week program, and at an 8-week follow-up. Assessments include the Mini Mental Test, pain scores, disability of the arm, shoulder, and hand (DASH), proprioception measured with an inclinometer, and fear of movement using the Tampa Kinesiophobia Scale. Motor imagery ability will be measured with the Movement Imagery Questionnaire (MIQ-R). The study tracks changes in these outcomes over time to understand the effects of motor imagery training.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
1 location
E

Actively Recruiting

Researchers are investigating the effectiveness of desensitisation and pain neuroscience education in adults aged 18 to 65 diagnosed with Carpal Tunnel Syndrome (CTS) who have a mixed pain type, including neuropathic and nosiplastic pain. The study applies the 7-step clinical criteria from the International Association for the Study of Pain to identify the nosiplastic pain phenotype in patients with CTS. Participants with this mixed pain type are randomly assigned to one of two groups to compare the treatments. One group will receive desensitisation therapy, a technique aimed at reducing or normalizing the body's response to certain sensations. The other group will receive both desensitisation and pain neuroscience education, which is designed to change patients' beliefs and understanding about their pain. Treatments are given during the study period, and participants are monitored at the beginning, after 6 weeks, and again 3 months later. Participants will undergo several assessments including pain rating scales, symptom severity and functional status questionnaires, and measurements of pressure pain threshold. Questionnaires to evaluate pain-related thoughts and movement fears will also be used. Data will be analyzed using statistical tests to compare changes in pain intensity, symptom severity, function, pain catastrophising, and kinesiophobia between the two groups over time.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
1 location

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