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NCT ID: NCT05270668 Recruiting - Clinical trials for Interstitial Lung Disease

Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

ATHENA-SSc-ILD
Start date: July 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

NCT ID: NCT05269394 Recruiting - Dementia Clinical Trials

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

DIAN-TU
Start date: December 22, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.

NCT ID: NCT05268601 Recruiting - COVID-19 Clinical Trials

COVID-19 and Disease Progression to the Severe Form: A Study on the Use of Monoclonal Antibodies Against SARS-CoV-2

CONDIVIDIAMO
Start date: October 14, 2021
Phase:
Study type: Observational

This is a national multicentre observational study with retrospective and prospective data collection to assess the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies. The subjects enrolled will be patients with early infection of SARS-CoV-2, paucisymptomatic, with risk factors for evolution to the severe form (according to AIFA criteria). Also, hospitalised subjects will be enrolled to receive SARS-CoV-2 monoclonal antibodies because of negative serology (according to AIFA criteria). It is estimated to enrol about 1000 subjects. Patients will be evaluated at enrollment and 28 days following administration to collect data on symptoms, possible hospitalization and final clinical outcome (alive with symptoms, alive without symptoms, alive with symptoms and hospitalized or deceased). Data will be collected using a dedicated electronic Case Report Form (eCRF).

NCT ID: NCT05267613 Recruiting - Erosive Esophagitis Clinical Trials

Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

EE
Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

NCT ID: NCT05267509 Recruiting - Glioma, Malignant Clinical Trials

An Integrated Radio-immunological Approach

IMMUNO-IMAGING
Start date: February 23, 2022
Phase:
Study type: Observational

The most aggressive primary brain tumors in adults, glioblastomas, are characterized by a profound local and systemic immune suppression. During tumor progression, the infiltration of inflammatory leukocytes, especially of myeloid origin, endowed with immunosuppressive function is observed. Aim of this study is to evaluate myeloid cell infiltrate and iron metabolism in tumor-associated macrophages by combining a multimodal MRI imaging technique with immunophenotyping of the tumor microenvironment.

NCT ID: NCT05266521 Recruiting - Low Back Pain Clinical Trials

Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System

Start date: November 7, 2021
Phase: N/A
Study type: Interventional

The zLOCK Facet Stabilization System is a fixation device intended to provide posterior stability in the lumbar spine fusion procedure. The system can be placed either as an adjunct to an inter-vertebral anterior cage or as stand-alone with/ without additional decompression of the dural sac or nerve roots as appropriate for the specific patient and surgeon's discretion. The zLOCK implant is placed inside the facet to stabilize the motion and enhance the bony fusion of the joint. The zLOCK Facet Stabilization System is intended for single-level stabilization of a spinal motion segment in order to promote bony fusion of the joint. The zLOCK system is indicated for use from L1-L2 to L5-S1 joints. The zLOCK implant is inserted into the facet joint space while adapting to the joint's changing geometry. Stabilization is achieved by a firm grip of each joint bone and resisting any relative motion. The zLOCK implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness procedure duration and shortening the recovery period. This pivotal study was designed in order to assess the safety and effectiveness of the zLOCK system.

NCT ID: NCT05265988 Recruiting - Carcinoma Prostate Clinical Trials

Multiparametric Assessment of Bone Response in mCRPC Patients Treated With Cabozantinib

MERIDIAN
Start date: October 29, 2021
Phase: Phase 2
Study type: Interventional

Multiparametric assesment of bone response in mCRPC patients treated with Cabozantinib upon progression to chemotherapy and next generation hormonal agents: a phase II study

NCT ID: NCT05264753 Recruiting - Clinical trials for Patent Ductus Arteriosus

PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Start date: December 20, 2021
Phase:
Study type: Observational [Patient Registry]

This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA by using Occlutech Occlusions-Pusher (OOP) in patients with patent ductus arteriosus defects. Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

NCT ID: NCT05263999 Recruiting - Clinical trials for Graft Versus Host Disease

A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids

NCT ID: NCT05263934 Recruiting - Clinical trials for Eosinophilic Granulomatosis With Polyangiitis

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)

OCEAN
Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.