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NCT ID: NCT05637112 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

ASTER
Start date: February 27, 2023
Phase:
Study type: Observational

Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.

NCT ID: NCT05636527 Recruiting - AAT9 Clinical Trials

Further Evaluation of Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System

ARCUS
Start date: November 9, 2022
Phase:
Study type: Observational

The goal of this observational study is to collect more clinical information on how safe it is, and how well the NEXUS™ Aortic Arch Stent Graft System works for the treatment of aortic aneurysms, which is a bulg involving the aortic arch in the standard-of-care setting following CE-approval. The main question[s] it aims to answer are: - Early mortality, defined as lesion related death, or any death that occurs within 30 days following the procedure - Safety outcomes throughout the study - Device failure throughout the study - Procedural and hospitalisation information Participants will be treated per institutional standard of care that includes the following: - Medical History, blood tests, ABI, Rutherford Classification, physical examination, CTA, ECG, Echocardiography, and neurological assessment at baseline - Collection of procedural and hospitalisation information - Follow-up information will be collected at discharge, after 30 days, after 6 months and annually through to five years. Data collected may include: AE/SAE, physical examination, AKI classification, neurological assessment, lab tests, CTA

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05636046 Recruiting - Cardiac Disease Clinical Trials

Transseptal Italian Registry (TITLE)

TITLE
Start date: November 20, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to learn about the changing over the time of transseptal (TSP) catheterization for catheter ablation of arrhythmias in the left heart. This study aims to investigate if auxiliary tools for TSP catheterization improved the safety and efficacy.

NCT ID: NCT05635708 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

Start date: March 7, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).

NCT ID: NCT05634499 Recruiting - Endometrial Cancer Clinical Trials

A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer

EndomERA
Start date: June 27, 2023
Phase: Phase 2
Study type: Interventional

This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer.

NCT ID: NCT05634200 Recruiting - Hemoptysis Clinical Trials

Utility of Bronchoscopy in Patients With Haemoptysis and Negative Chest CT Scan

Start date: October 1, 2022
Phase:
Study type: Observational

Conflicting evidence exist in the literature on the utility of bronchoscopy in patients with haemoptysis and negative/non-diagnostic chest CT scan. The primary aim of this prospective, observational, multicenter study is to evaluate the utility of bronchoscopy in patients with haemoptysis and negative/non-diagnostic CT scans. Secondary aims are related to the utility of bronchoscopy to detect occult malignancies, the source of the bleeding and the clinical features of the cohort

NCT ID: NCT05634070 Recruiting - Pectus Excavatum Clinical Trials

Pectus Excavatum Camouflage (IT)

Start date: December 14, 2022
Phase: N/A
Study type: Interventional

The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT). The study aims to demonstrate the safety and clinical performance of the insertion of an absorbable "medical-grade polycaprolactone-PCL Pectus Scaffold" in the thorax region with Autologous Fat Grafting in the correction of congenital Pectus Excavatum unsuitable for conventional treatment with stable cardio-respiratory function. The PCL Pectus Scaffold-based design has the potential to induce sustained regeneration to fill large volume pectus excavatum defects, with the added benefit of being light weight and resorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.

NCT ID: NCT05633784 Recruiting - Diabetes Mellitus Clinical Trials

Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes

TELEMECHRON
Start date: August 18, 2022
Phase: N/A
Study type: Interventional

The progressive ageing of the population of industrialized countries is accompanied by a dramatic increase in the prevalence of chronic multi-pathologies. In the general population, HF is associated with a higher prevalence of T2DM compared with patients without HF and with marked regional differences observed in Europe and the rest of the world. In clinical trials of chronic HF patients, the prevalence of T2DM is approximately 30% in patients with reduced or preserved ejection fraction and rises to as much as 45% in hospitalized patient registries. A complex drug regimen is often associated with low adherence in patients with HF and T2DM and poor adherence is associated with adverse clinical events. Similarly, adherence to recommendations regarding lifestyle changes, such as increasing physical activity, is often limited despite these changes' favourable effects on the patient. Therefore, interventions are needed to improve all these factors and optimize adherence. The inclusion of telemedicine (telenursing, telerehabilitation, mHealth) focused on health and correct behaviour can create opportunities to implement customized and scalable solutions in populations at risk. The project will aim to evaluate for patients with chronic diseases with a complex phenotype (heart failure and type II diabetes mellitus) the effectiveness of a remote surveillance program with particular attention to lifestyle changes.

NCT ID: NCT05632952 Recruiting - Obesity Clinical Trials

ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials

PSICHE-EROS
Start date: November 1, 2022
Phase:
Study type: Observational

The aim of this study is to evaluate safety and effectiveness of a hybrid mesh (GORE® SYNECOR Intraperitoneal Biomaterial) in patients with a BMI of 30 kg/m2 or more undergoing laparoscopic ventral hernia repair (LVHR) with intraperitoneal position of the mesh.