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NCT ID: NCT05883904 Recruiting - Clinical trials for Primary Myelofibrosis

Real World Evidence of Fedratinib Effectiveness in MF

REALFed
Start date: January 29, 2024
Phase:
Study type: Observational

This is a multicenter prospective and retrospective observational clinical study in patients with primary or post polycythemia vera or post essential thrombocythemia myelofibrosis to test the efficacy of fedratinib in the rea world. Participants will be managed according to the clinical practice of the participating Center. All Centers will be Italian Hematology Units belonging to the GIMEMA Organization in Italy.

NCT ID: NCT05883891 Completed - Alcoholic Hepatitis Clinical Trials

Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

AH2023
Start date: June 1, 2017
Phase:
Study type: Observational

Alcoholic hepatitis (AH) is the most severe form of acute alcohol-related liver disease. Maddrey's discriminant function (mDF) >32 defines the severe form of AH, which is associated with a high mortality. Corticosteroid therapy (CS) represents the main medical treatment that may reduce short-term mortality. Lille score at day 7 assesses the therapeutic response to steroid therapy. At present, no parameters able to predict the response to steroid therapy have been highlighted. The mDF depends mainly on prothrombin time (PT). Aim of the present study was to evaluate if the PT value could predict the response to CS in severe AH (sAH).

NCT ID: NCT05883878 Recruiting - Clinical trials for Cardiovascular Diseases

Innovative Approaches for Personalised Cardiovascular Prevention

INNOPREV
Start date: July 24, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases (CVD) in the population. The main questions it aims to answer are: - efficacy and safety of the intervention - how to implement the interventions in the NHS Participants will be randomized in one of the four parallel arms: - standard of care; - genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS); - digital intervention with a wearable device and its app; - digital intervention and genetic testing (PRS) The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline, alone or in combination with the use of a wearable device, on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline, nor respect to subjects receiving traditional risk assessment plus adopting wearable devices.

NCT ID: NCT05883644 Recruiting - Clinical trials for Advanced Hepatocellular Carcinoma

Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

SIERRA
Start date: June 27, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.

NCT ID: NCT05882877 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-ASCEND
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

NCT ID: NCT05882734 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Start date: September 13, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies..

NCT ID: NCT05881408 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)

ENVISION
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study. Participants will be in the study for approximately 128 weeks. All participants will have the opportunity to receive intravenous (IV) delandistrogene moxeparvovec in either Part 1 or Part 2.

NCT ID: NCT05881343 Completed - Clinical trials for Coronavirus Infection

Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery

COVID19&SURG
Start date: July 18, 2020
Phase:
Study type: Observational

Over the last months, the Rizzoli Orthopedic Institute in Bologna, Italy, has drained orthopedic urgencies from all other hospitals in the urban and suburban area. In this context urgencies are defined as fractures and primary or metastatic bone lesions with indication to non-deferrable surgery. A subset of these patients tested positive for SARS CoV 2, either before or after the surgical procedure. Anesthesiological clinical management of covid19 cases is complicated by the consequences of the viral infection on respiratory and cardio-vascular systems, renal function and coagulation. Similarly, management of asymptomatic patients is challenging because of the lack of data on possible specific complications. This study will report a snapshot of our early experience on perioperative clinical management of patients undergoing orthopedic surgery in the presence of SARS CoV 2 infection, ascertained or not at the time of surgery.

NCT ID: NCT05880641 Recruiting - Clinical trials for Peripheral Arterial Disease

Use of Shockwave M5+ IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access

SHOCK-ACCESS
Start date: June 26, 2023
Phase:
Study type: Observational

The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.

NCT ID: NCT05880420 Completed - Infections Clinical Trials

EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)

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

Cancer patients need central venous access according to the different types of chemotherapy and support drugs for their treatment path. The presence of a central vascular access brings mechanical issues, thrombotic and infectious complications that can undermine the patient's health and the life of the catheter, therefore the management of venous accesses is clinically relevant. The prevention of infections remains mainly based on correct hand washing and compliance with aseptic techniques. This is a multicenter intervention study is composed by a single experimental arm (home) and a calibration arm (outpatient). The study is designed to evaluate that the complication rate recorded in the two groups are similar.