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NCT ID: NCT06283966 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

THARROS
Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

NCT ID: NCT06275763 Recruiting - Hypertension Clinical Trials

Optimal Medical Treatment of Difficult-to-treat Hypertension

OPTIMAL-HT
Start date: October 20, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are <65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs

NCT ID: NCT06275399 Recruiting - Atherosclerosis Clinical Trials

Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery

INTERFORCE
Start date: July 21, 2023
Phase:
Study type: Observational [Patient Registry]

The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery.

NCT ID: NCT06275204 Recruiting - Gastric Cancer Clinical Trials

H. Pylori Screen-and-treat Study in a Population of Young Adults

Start date: March 4, 2024
Phase:
Study type: Observational

Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia. Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up. Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention.

NCT ID: NCT06271421 Recruiting - Clinical trials for Glioblastoma Multiforme

NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme

ANCHIALE
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study. The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM. The main questions it aims to answer are: 1. how NanoTherm therapy influences overall survival, and progression free survival; 2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life. Participants will undergo: - initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life; - standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field; - between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation; - after the first activation (10th day), the catheter will be removed; - subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day; - for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed; - during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted. Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects.

NCT ID: NCT06269484 Recruiting - Liver Cirrhosis Clinical Trials

A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK

ZEAL UNLOCK
Start date: February 15, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis.

NCT ID: NCT06269107 Recruiting - Type 2 Diabetes Clinical Trials

A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)

COMBINE 4
Start date: February 15, 2024
Phase: Phase 3
Study type: Interventional

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).

NCT ID: NCT06268873 Recruiting - Clinical trials for Chronic Kidney Disease and Hypertension

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

NCT ID: NCT06268613 Recruiting - Clinical trials for Non-small Cell Lung Cancer Stage II

A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy

Start date: January 16, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is: • What the body does to the study drug, which is called "pharmacokinetic" Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected. Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.

NCT ID: NCT06268574 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML

RIVER-52
Start date: January 23, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients.