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NCT ID: NCT05758805 Recruiting - Atrial Fibrillation Clinical Trials

Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)

ESO-SAFE-HP-RF
Start date: January 8, 2024
Phase: N/A
Study type: Interventional

This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are: - Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen. - Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development. - Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.

NCT ID: NCT05757869 Recruiting - Atrial Fibrillation Clinical Trials

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

LIBREXIA-AF
Start date: April 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

NCT ID: NCT05757271 Recruiting - Clinical trials for Peripheral Arterial Disease

Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease

Start date: October 23, 2019
Phase:
Study type: Observational

Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. In addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease. The goal of this observational study is to evaluate the potential use of circulating klotho and FGF23 serum levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in patients with peripheral artery disease (PAD) and chronic limb threatening ischemia (CLTI) requiring a procedure of endovascular revascularization. The main questions it aims to answer are: - association between klotho and FGF23 serum levels and major adverse limb events (MALE) after lower extremity revascularization. - association between klotho and FGF23 serum levels and major adverse cardiovascular events (MACE) after lower extremity revascularization. Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and FGF23 before the endovascular procedure. Incidence of MACE and MALE will be collected in a 12-months follow-up and will be associated with klotho and FGF23 serum levels at baseline.

NCT ID: NCT05756621 Recruiting - Cardiac Arrest Clinical Trials

Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest

SUPER-CAT
Start date: January 15, 2022
Phase:
Study type: Observational

Status epilepticus (SE) is found in 20-30% of patients in coma after cardiac arrest, is often refractory to medical therapy and is considered a negative prognostic factor. Intensity and duration of treatment of refractory and super-refractory post-anoxic SE pose the ethical dilemma between futility of treatments and, conversely, their premature suspension. A recent study by the Epilepsy Center of the San Gerardo Hospital has shown that patients with super-refractory post-anoxic SE and favorable prognostic indicators can achieve a good functional outcome in more than 40% of cases, if treated with intensive and protracted therapy. However, there is profound uncertainty about the best combination of antiseizure medications and anesthetics to use in this condition. A combined anti-glutamatergic therapy with ketamine (anti-NMDA receptor) and perampanel (anti-AMPA receptor), aimed at counteracting the excitotoxicity linked to global cerebral ischemia, could be particularly effective in the treatment of super-refractory SE with post-anoxic etiology. Preliminary results in the first 26 patients treated in the Coordinating Center of the project indicate that this therapy appears safe and highly effective (80% SE resolution, 40% good neurological outcome). The aim of the SUPER-CAT study is to investigate the efficacy and safety of combined therapy with ketamine and perampanel (dual anti-glutamatergic therapy) in patients with post-anoxic super-refractory status epilepticus, compared to other therapies, using a multi-centre, retrospective, cohort study design.

NCT ID: NCT05756582 Recruiting - Tuberculosis Clinical Trials

Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students

CROSSWORD
Start date: November 17, 2021
Phase:
Study type: Observational

This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection [LTBI], defined as individuals infected with Mycobacterium tuberculosis with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.

NCT ID: NCT05756543 Recruiting - Parkinson Disease Clinical Trials

Counterfactual Thinking and Decision-making in Parkinson's Disease

CT_PD
Start date: March 30, 2022
Phase:
Study type: Observational

The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals affected by Parkinson's Disease when compared to healthy individuals.

NCT ID: NCT05756530 Recruiting - Anorexia Nervosa Clinical Trials

The Experience of Affective Touch in Anorexia Nervosa

AffTouch_AN
Start date: October 6, 2021
Phase:
Study type: Observational

The aim of the present research will be to verify if the pleasantness of affective touch is comparable between women with AN and healthy women while measuring the level of social anhedonia and the lifespan experience of affective touch.

NCT ID: NCT05756452 Recruiting - Clinical trials for Acute Coronary Syndrome

Linking Cardiac Autonomic Dysfunction and InfLammation in Patients With Acute Coronary Syndromes

CADILACS
Start date: February 17, 2023
Phase: N/A
Study type: Interventional

Subclinical inflammation plays a critical role in all stages of the atherosclerotic process, from the initiation of the fatty streaks to the development of plaque instability and rupture, causing myocardial ischemia and acute coronary syndromes (ACS). A few studies have suggested that the autonomic nervous system (ANS) and the inflammatory response are intimately linked. Accordingly, a relation between impaired cardiac autonomic tone and increased markers of inflammation has been reported in healthy subjects as well as in patients with type 1 diabetes mellitus, chronic coronary syndrome or decompensated heart failure. To get insight in the controversial relationship between cardiac autonomic dysfunction and inflammation in patients with ACS both with and without obstructive CAD and assess the precise mechanisms and molecular pathways by which these two pathophysiological conditions mutually influence each other, to characterize their prognostic implications and identify possible targets for novel therapeutic strategies.

NCT ID: NCT05756270 Recruiting - Clinical trials for Mild Cognitive Impairment

Clinical Applicability of pCASL as a Substitute for FDG-PET in MCI and SCD Patients

CAPE
Start date: June 3, 2022
Phase:
Study type: Observational

The goal of this observational study is to compare cerebral perfusion patterns with pseudo-continuous arterial spin labeling (pCASL) and brain metabolism patterns with fluorodeoxyglucose-position emission tomography (FDG-PET) in patients with mild cognitive impairment (MCI) and subjective cognitive decline (SCD). The main questions it aims to answer are: - Do pCASL sequences identify hypoperfusion patterns that correlate well with FDG-PET hypometabolic patterns? - Are there differences in this correlation in terms of cerebrospinal fluid (CSF) profiles? - Can hypoperfusion patterns in pCASL predict conversion to dementia? Participants will undergo brain 3 Tesla magnetic resonance imaging (MRI), FDG-PET, lumbal puncture and blood collection to analyze amyloid beta and tau, yearly detailed neuropsychological tests for three years.

NCT ID: NCT05756153 Recruiting - Clinical trials for Advance Non-small Cell Lung Cancer

A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

Start date: April 25, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC