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.
Previous research has shown how parental responses can affect ADHD symptoms by triggering dysfunctional cyclic processes. Therefore, it may be useful within rehabilitative treatments to include parent training (PT). Recent literature data have demonstrated the potential of using virtual reality in the rehabilitation of children with ADHD. No study has been conducted on the use of virtual reality (VS) within a PT program. It is possible to hypothesize that virtual reality, by providing a controlled environment can help the parent improve his or her ability to self-control and perceive the child's difficulties. This allows the parent's empathizing skills to be implemented and reinforces the educational techniques learned during the parent training intervention.
Prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer
STERO-AHF is a pilot, prospective, multicenter, randomized, open-label, controlled study aimed to evaluate the diuretic efficacy and early clinical benefit of corticosteroid therapy administered for 7 days, in addition to standard therapy, in patients hospitalized for acute heart failure (AHF) and with evidence of insufficient diuretic response. Eligible patients will be randomized 1:1 to receive either standard-of-care alone (control group) or standard-of-care plus corticosteroid therapy (experimental group) for up to 7 days. Patients will be followed to 30 days.
The aim of this observational prospective study is to investigate the role of Magnetic Resonance Fingerprinting in preoperative assessment of early cervical cancer
Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m
This study will evaluate the pharmacokinetics (PK) and safety of risdiplam in participants with spinal muscular atrophy (SMA) under 20 days of age at first dose.
The aim of this project is to develop an Augmentative and Alternative Communication intervention through the use of Eye tracker system.
This is an open, non-comparative, Single-centre Post Marketing Clinical Followup (PMCF) study aimed to enrol patients with medium and deep facial sagging, facial volume defects and/or lips volume and contours defects. The investigation will be useful to collect Investigational Product' real world safety /performance evidences in normal clinical practice. Each subject, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted. At baseline visit (Visit 0), as per clinical practice, the subject can be treated with one or more of the below ALIAXIN products, depending on investigator clinical evaluation and decision: - ALIAXIN EV: Essential Volume - ALIAXIN FL: Lips - ALIAXIN SR: Shape & Restore - ALIAXIN GP: Global Performance - ALIAXIN LV: Lips Volume According the investigator judgment and IP' Instruction For Use (IFU), each subject can be treated in one or more of following face area: - Temporal / frontal area - Orbital / Malar area - Perioral area - Lips. For the pre- and post-treatment clinical evaluations, a LifeViz® Mini 3D camera (QuantifiCare) will be used for face-images capture. A LifeViz® Micro 3D camera (QuantifiCare) will be used for adjuvant images capture, only in specific conditions (e.g. nasolabial folds and marionette lines) and according to the Principal Investigator judgment, to facilitate the clinical evaluation. As per clinical practice, the treatment can be repeated at touch up visit (Visit 1), after 15 days from Visit 0, according the investigator clinical evaluation and decision, to maintain/refine the obtained results. Moreover, after 6 months from Visit 0, as per clinical practice, a visit ( Visit 2, End of Study Visit) will be performed to collect and evaluate the safety and performance of treatment(s) performed. Considering the normal clinical practice, after Visit 2, according the investigator judgment and after a new Informed Consent Form signature, the subject can be enrolled in a new screening phase as per clinical study design. The re-enrolled subject should meet all inclusion and none exclusion criteria. In the new CRF will be reported the previous subject's identification number.
In recent years, the application of increasingly advanced methods of ex-vivo cell culture and cell engineering has made it possible to develop new cellular therapeutic platforms including the "CAR (Chimeric Antigen Receptor) - T cell therapy". CAR-T cell therapy is a therapy that uses T lymphocytes engineered to express a chimeric receptor directed against a specific antigen, theoretically applicable to the treatment of all neoplasms but currently more widely used in the treatment of haematological malignancies. One of the most innovative aspects introduced with CAR-T cell therapy is that of living-drug, cells that act as a drug as well as a means to build specific immunity against the neoplasm. The advantages of this therapy are therefore represented by the possibility of refueling the patient's immunity, deficient in the control of the neoplastic disease, with lymphocytes capable of expressing an antineoplastic activity with mechanisms not subject to restriction of HLA-mediated antigen recognition. However, the use of CAR-T therapies is not free from potentially serious and sometimes lethal adverse events; in the toxicity profile the following are recognizable as peculiar: - cytokine release syndrome (CRS) - B-cell aplasia (hypogammaglobulinemia) - neurological adverse reactions - haematological toxicity - infections. Therefore, considering that on the one hand adverse events are not negligible and on the other hand that a percentage > 50% of patients lose the response obtained, it is necessary to improve the therapeutic profile of CAR-T cell therapy by increasing its efficacy and reducing its toxicity . Both of these strategies are linked to the understanding of the resistance mechanisms of neoplastic cells, as well as to the biology of CAR-T cells and of all the cellular (microenvironment) and non-cellular systems with which they interact.
In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. MRF parameters can be also correlated to prognosis, both in terms of disease-free survival (DFS) and overall survival (OS).