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NCT ID: NCT04735432 Completed - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

ADAPTsc
Start date: February 5, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)

NCT ID: NCT04735289 Recruiting - Osteosarcoma Clinical Trials

Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma

Metabol-Sarc
Start date: March 10, 2021
Phase:
Study type: Observational [Patient Registry]

Osteosarcoma and Ewing sarcoma treatment has not changed in the last 30 years. For other types of cancer the epidemiologic and prognostic correlations between dietary behavior, lifestyle and metabolic alterations (i.e.obesity, insulin-resistance) are well known (breast cancer, prostate cancer, colon cancer). However, no epidemiological or prognostic data are available about the metabolic profile and lifestyle behaviors in patients with osteosarcoma and Ewing'sarcoma and only few preclinical studies are available. An in vitro study showed a higher glucose and glutamine consumption from metastatic osteosarcoma cells compared to primary tumor osteosarcoma cells. The effect of the intestinal microbiota into the metabolism of nutrients, drugs, inflammation, epigenetic and immune response was found not only correlated to gastrointestinal tumors but also to other tumors outside gastrointestinal system as well The aim of this study is to investigate if there are differential dietary habits, metabolome, microbiota or immune profile in patients with bone sarcoma compared to a control population in a 1:2 multicenter study.

NCT ID: NCT04735146 Recruiting - Pregnant Women Clinical Trials

Adapted Physical Activity to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women (WELL-DONE!Study)

WELL-DONE!
Start date: February 20, 2021
Phase: N/A
Study type: Interventional

The aim of the WELL-DONE! Study is to co-design, using different professional figures (midwives, psychologists, master's degree in motor science) but also taking into consideration the pregnant women's point of view, an intervention of adapted physical activity for pregnant women, included in the birth accompaniment courses and conducted by midwives, and to evaluate its effectiveness in terms of quality of life, well-being, levels of physical activity and satisfaction with respect to the proposed intervention.

NCT ID: NCT04735042 Recruiting - Type 2 Diabetes Clinical Trials

SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.

UTI-flog
Start date: October 7, 2020
Phase:
Study type: Observational

In this observational study, 60 subjects with type 2 diabetes (T2D) and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor or a fixed dose combination of SGLT-2 inhibitor with a DPP4-inihibitor for 12 weeks. Measures will be performed at baseline and after 12 weeks of treatment, as per good clinical practice.

NCT ID: NCT04735016 Recruiting - Arrhythmia Clinical Trials

DiamondTemp Global Registry

Start date: April 22, 2021
Phase:
Study type: Observational [Patient Registry]

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

NCT ID: NCT04735003 Recruiting - Clinical trials for Tricuspid Valve Insufficiency

Transcatheter Interventions for Tricuspid Insufficiency in Italy

TRIC-IT
Start date: January 30, 2021
Phase:
Study type: Observational [Patient Registry]

This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.

NCT ID: NCT04734873 Terminated - Covid-19 Clinical Trials

CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.

NCT ID: NCT04734522 Completed - Presbyopia Clinical Trials

Assessment of Progressive Lens Designs

TBPD
Start date: October 19, 2020
Phase: N/A
Study type: Interventional

Non-invasive double-blind randomised comparative study on presbyopic subjects wearing progressive lenses.

NCT ID: NCT04734444 Recruiting - Glioblastoma Clinical Trials

SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF). The performance will be assessed by analysis of the contrast-to-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale. This is a prospective, multi-centre single-arm study where the performance of SonoClear ACF relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of HGG and LGG at up to 10 sites will be included. Additionally, safety data are collected at 30 days and 6 months post-procedure.

NCT ID: NCT04733807 Recruiting - Covid-19 Clinical Trials

Antibodies Response to mRNA Vaccine Against Covid-19

SCAREAID
Start date: January 28, 2021
Phase:
Study type: Observational

Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this study to monitor IgG evolution after vaccination in the participant hospital settings, which includes 500 subjects.