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NCT ID: NCT06083675 Withdrawn - Clinical trials for Diabetes Mellitus, Type 2

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Start date: January 26, 2024
Phase: Phase 3
Study type: Interventional

This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

NCT ID: NCT06083337 Recruiting - Clinical trials for Coronary Artery Disease

Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography

VIRDICT
Start date: January 22, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effect of standard of care management vs. CaRi-Heart based management on vascular inflammation in patients with increased Fat Attenuation Index-Score. The main questions it aims to answer are: - Does treatment intensification reduce vascular inflammation detected by perivascular fat imaging to a greater extent than standard of care treatment? - Do changes in vascular inflammation biomarkers correlate with changes in lipid metrics or inflammatory biomarkers, such as interleukin-6? Participants will be randomized either to standard of care treatment or intensified treatment with maximum dose of atorvastatin +/- low dose of colchicine. After their inclusion, study participants will be followed-up for 6 months with regular monitoring for adverse events and blood will be drawn at 3 and 6 months. After the 6-month follow-up, participants will undergo CCTA imaging for fat attenuation index measurements. Researchers will compare standard of care and vascular inflammation-based treatment to see if inflammation-based treatment is more potent against vascular inflammation.

NCT ID: NCT06081205 Recruiting - Clinical trials for Acute Myocardial Infarction

Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease

Start date: April 27, 2023
Phase:
Study type: Observational

This is a registry of the patients that are admitted to CICU and treated by the Scientific Staff of the 2nd Department of Cardiology, due to an acute cardiovascular disease (acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, cardiac tamponade etc) in order to investigate the clinical characteristics of the patients, their outcome, identify the factors that could predict the in-hospital mortality and compare the results with the predicted by established risk scores. Furthermore, the study will investigate the one-year mortality and also the major adverse cardiac events (MACE - acute myocardial infarction, stroke, or cardiovascular death) will be measured.

NCT ID: NCT06080529 Completed - Clinical trials for Exercise Energy Expenditure

Metabolic Cost of Sandbag Training

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

This study aims at investigating the metabolic cost of several fundamental exercises with sandbag. Sandbag training has become a popular training modality that is efficiently used to improve cardiovascular status and physical performance. Despite its widespread use and popularity the metabolic cost of exercises using sandbag remains to be elucidated. Therefore, the metabolic cost of various fundamental exercise with sandbag will be determined to aid the planning of exercise training programs.

NCT ID: NCT06080516 Completed - Clinical trials for Exercise Energy Expenditure

Metabolic Cost of Kettlebell Training

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

This study aims at investigating the metabolic cost of several fundamental exercises with Kettlebell. Kettlebell training has become a popular training modality that is efficiently used to improve cardiovascular status and physical performance. Despite its widespread use and popularity the metabolic cost of exercises using kettlebell remains to be elucidated. Therefore, the metabolic cost of various fundamental exercise with kettlebell will be determined to aid the planning of exercise training programs.

NCT ID: NCT06079970 Recruiting - Lung Cancer Clinical Trials

Confocal Laser Endomicroscopy VERification

CLEVER
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy. The main question[s] it aims to answer are: To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure). Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.

NCT ID: NCT06077864 Recruiting - Obesity Clinical Trials

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

Start date: November 17, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.

NCT ID: NCT06077760 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

INTerpath-002
Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

NCT ID: NCT06071273 Completed - Clinical trials for Cardiovascular Diseases

Online Platform for Self-service of Patients With Chronic Cardiovascular Diseases

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to define the requirements and characteristics of the software that will be developed for the project "Creation of a platform for self-service of people living with chronic cardiovascular diseases in an understandable, clear, complete, consistent and verifiable manner. The project concerns the design and implementation of a long-term program of therapeutic exercise and evaluation, by exercise and health professionals, of the anatomical and functional adaptations of exercise in patients and athletes with cardiovascular diseases. Essentially, it is a program of recording and monitoring cardiovascular rehabilitation in the form of systematic exercise of the patient both at home and in sports venues, which will contribute to the prevention of cardiovascular events in conditions of fatigue and at rest as well as to the gradual rehabilitation of the patient who performs a physical activity. Depending on the individual's functional capacity and health issues, combined with monitoring the patient's vital signs (such as blood pressure, heart rate, oxygen saturation, body temperature) the exercise professional will create an individualized, targeted exercise program with ultimate aiming at its rehabilitation with the help of physical activity and the improvement of its functional performance and by extension the quality of life of the individual. At the same time, the project will seek to motivate patients to remain committed to the physical activity program, with the aim of faster reintegration into their daily life.

NCT ID: NCT06069310 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma

MepoRiNaPAs
Start date: September 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about clinical and functional outcomes in patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma and patients with Chronic rhinosinusitis with nasal polyps only treated with mepolizumab compared to healthy controls. Participants will be asked to give nasal, blood and sputum samples before mepolizumab administration (T0) and at 3 (T3), 6 (T6) and 12 (T12) months after mepolizumab initiation The main aims are to identify airways microbiota modifications and differential gene expression after mepolizumab initiation. Researchers will compare: - Patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma - Patients with Chronic rhinosinusitis with nasal polyps only - Healthy subjects The research will address the following questions: 1. What are the prospective clinical and functional outcomes of mepolizumab treatment 2. What is the impact of mepolizumab therapy on the airways microbiota and how this may relate to a potentially reduced need for steroids 3. What are the host differential gene expression patterns and the immune/inflammatory (cytokines/chemokines) profile alterations in airways microenvironment and in systemic circulation in response to therapy 4. What are the associations between host and microbiome variables for building up diagnostic and predictive biomarker classifiers of responsive disease endotypes