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NCT ID: NCT06220006 Recruiting - Atrial Fibrillation Clinical Trials

Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance

PULSED-ICE-CMR
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

This randomised study will compare pulsed field ablation and cryoballoon ablation with respect to ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation. Patients scheduled for first-time AF ablation will be randomised in a 2:1 fashion to receive PVI-only, either by pulsed field ablation (Farapulse Pulsed Field Ablation System, Boston Scientific) or cryoballoon ablation (Medtronic Cryoballoon Ablation System).

NCT ID: NCT06219941 Recruiting - Gastric Cancer Clinical Trials

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Start date: December 13, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.

NCT ID: NCT06218121 Recruiting - Depression Clinical Trials

Update on the Detection of Frailty in the Older Adult

Start date: April 20, 2024
Phase:
Study type: Observational [Patient Registry]

The main objective is to update the diagnostic assessment of frailty by correlating several variables with the ultrasound image of the frail elderly patient. Secondarily, the investigators intend to collect and analyze data on functional capacity and quality of life variables on the evolution of musculoskeletal symptoms, as well as on pain and psychological variables. Similarly, it is intended to make a record of different profiles and subtypes of frail older adult patients to be stored in Big Data in order to establish therapeutic intervention plans that allow both the evaluation and treatment of patients.

NCT ID: NCT06218108 Recruiting - Clinical trials for Rectal Cancer Stage I

Multicenter Observational Study Taulí-T1 Classification for the Management of pT1 Rectal Adenocarcinoma

TAUTEM-pT1
Start date: October 2, 2023
Phase:
Study type: Observational

BACKGROUND: Rectal cancer is the sixth most common neoplasm in Spain. In the early stages (pT1-N0), the treatment of choice is transanal endoscopic microsurgery. Treatment may be expanded to radical surgery if there are poor prognostic factors for the presence of metastatic lymph nodes and a risk of recurrence (up to 29%). The most determining histopathological factor is the degree of submucosal invasion. There are different classical classifications to assess this invasion, which pose difficulties in establishing objective and reproducible measurements. Casalots et al. propose a new classification (Taulí-T1) based on the measurement of residual healthy submucosa (hrSB), hypothesizing that a greater amount of healthy submucosa correlates with a better prognosis. Results show less healthy submucosa in the recurrence group, with a trend towards statistical significance (p=0.09). OBJECTIVE: To compare the Taulí-T1 classification with conventional quantitative classifications (Kitajima, Ueno) and qualitative classifications (sm1, sm2, and sm3 by Kudo and Kikuchi). METHODOLOGY: A multicenter observational retrospective cohort study comparing the Taulí-T1 classification with classical classifications in 317 patients with stage pT1 rectal adenocarcinoma, following the STROBE guidelines. The main variable is the measurement of tumor invasion in µm through hrSB, compared to the invasion of quantitative (Kitajima and Ueno) and qualitative (Kudo and Kikuchi) classical classifications. Concordance will be assessed with the intraclass correlation coefficient for quantitative variables and Cohen's weighted kappa for qualitative variables, with a 95% confidence interval and p<0.005.

NCT ID: NCT06217211 Recruiting - Fatigue Clinical Trials

Eficacia Ventilatoria y Remolacha

Start date: November 13, 2023
Phase: N/A
Study type: Interventional

The lung is the organ most affected by COVID-19. There are patients who successfully overcome the acute COVID-19 infection and their lungs return to a normal state. However, a significant number present dyspnea and fatigue as sequelae without having a pulmonary origin, but with a significant impact on functionality. In our published studies in relation to fatigue in patients with symptoms attributed to persistent COVID, the investigators have shown that there is muscle involvement, observing a decrease in mechanical efficiency. This muscle involvement causes stimulation of ventilation through the ergoreceptors, causing ineffective ventilation. This affectation can be explained by the findings obtained in the muscle biopsies that the investigators have performed, where the investigators observed a splitting of the basement membrane of the capillaries causing an alteration in the diffusion of metabolic substrates and oxygen. The main objective of our project is to be able to observe the response in ventilatory efficiency in patients with symptoms of post-covid fatigue after ingesting beet juice.

NCT ID: NCT06215716 Recruiting - NASH With Fibrosis Clinical Trials

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3.

NCT ID: NCT06215391 Recruiting - Als Clinical Trials

Customized Masks in Non-Invasive Mechanical Ventilation

Start date: December 10, 2023
Phase: N/A
Study type: Interventional

In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and quality of therapy mainly depend on it. The aim of this study is to investigate the usefulness of a customised mask approach to minimise leakage and upper airway obstruction. It will focus on ventilator registries and changes in the way they can be corrected with these customised masks. The process involves 3D face scanning and dedicated computer-aided design. The processing and manufacturing of the masks is based on additive manufacturing through 3D printing.

NCT ID: NCT06214819 Recruiting - Clinical trials for Coronary Artery Disease

Plan to Evaluate Early Endothelialization of a Polymer Free Sirolimus-eluting Coronary Stent System (VIVO ISARTM) Compared With Everolimus-eluting Durable Polymer Stent (XIENCE SkypointTM) in Patients Undergoing Percutaneous Coronary Intervention.

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

To evaluate the stent endothelialization (> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.

NCT ID: NCT06214780 Recruiting - Type 1 Diabetes Clinical Trials

Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas

HEAT1
Start date: January 22, 2024
Phase:
Study type: Observational

To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas

NCT ID: NCT06214052 Recruiting - HIV Infections Clinical Trials

VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1

Start date: February 7, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy (treatment-naïve). Data from this study will be used to decide how VH4524184 can be best included in a full-treatment regimen for HIV-1 in the future.