There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
To identify epigenetic-sensitive modifications and novel biomarkers linked to pathogenesis of pulmonary arterial hypertension (PAH), we will perform the first study analyzing differentially-methylated regions (DMRs) in circulating T cells (CD04+ and CD08+) isolated from peripheral blood of patients undergoing right heart catheterization. Moreover, we will perform RNA deep sequencing on lung tissue biopsies to validate if DNA methylation signatures in circulating T cells could reflect perturbations of gene expression in lung tissues.
The proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta). The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.
This is a prospective observational study with the aim to create an Italian database for the collection of data on diagnostic approach, therapy and follow up of patients affected by GEP-NET (gastro-enteric-pancreatic neuroendocrine tumours). Data for approximately 200 italian patients were already previously collected in the ENETS database (international database). ENETS decided to interrupt the collection of the data for an indefinite period. For this reason, through an amendment (number 1) to the protocol, ITANET (Italian Association Neuro-endocrine Tumors) decided to transfer the italian data into a national database and to go on with the collection/update of the data, in order not to lose important clinical information.
The study will evaluate the safety and efficacy of gene therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study with two thirds of participants assigned to gene therapy. The one third of participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
With this study the investigators propose to evaluate the satisfaction of the patients receiving antiretroviral treatment for HIV infection with standard everyday scheme, compared to patients receiving the same treatment with short-cycles of 4 days a week.
Although neuroplasticity of the brain is high in childhood, some neuropsychological sequelae could persist over the long term in children with Acquired Brain Injury (ABI). Many children with TBI, show deficits in pragmatic abilities that usually persist. Pragmatic difficulties have been observed also in children with sequelae of brain neoplasms . The lack of validated assessment tools for this population is described in literature. This limit is also valid for the tests that assess pragmatic abilities. The tests that SLPs usually administer investigate only the comprehension of verbal pragmatic and, sometimes the comprehension of linguistic and emotional prosody as well. This could lead to the risk that, sometimes, some pragmatic abilities might not be included in the evaluation. Moreover, it leads to a harder definition of the treatment aims and a harder objective demonstration of treatment outcomes. For these reasons, it is important to use an assessment tool that provides information on all the pragmatic abilities, not only in input but also in output. Some Italian researchers, recently, developed a test that investigates all these areas. It is called "ABaCo", and it is based on the Cognitive Pragmatics Theory. This theory is focused on cognitive processes underlying human communication. This test is standardized on a normative group of 300 adults. It was developed with the aim of assessing pragmatic abilities in adults with brain injuries. The assessor shows short videos to the patient, and he/her has to complete or understand the interaction transmitted through different communication channels. The authors also created an adaptation of this test for children aged 5 to 8.6 years old, modifying some items. After that, they administered this adaptation of the test to 390 healthy children. In another study, the authors administered this version of the batteries to children with autism spectrum disorders and to a control group of healthy children, matched by age and sex. Considering all the studies that already exist for the application of this assessment tool in childhood and adolescence, and the perspective of a standardization for developmental ages, this study aims to investigate whether this test could be useful to detect pragmatic difficulties also in children with ABI.
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA. The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB in all patients.
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis (MF) and other myeloid neoplasms.