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.
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile. The study takes place during a single visit, at the time of patient enrollment in the study
Multi-element interventions for first-episode psychosis (FEP) are promising but have mostly been conducted on non epidemiologically representative samples in experimental settings, raising the risk thereby of underestimating the complexities involved in treating onset psychosis in "real world" services. The PIANO Trial (Psychosis early Intervention and Assessment of Needs and Outcome) is part of a more broad-based research program (Genetics, Endophenotype and Treatment: Understanding early Psychosis - GET UP) and aims to: 1) test, at 9 months, the effectiveness, as compared to treatment as usual (TAU) of multi-component psychosocial intervention on a large epidemiologically-based cohort of FEP patients and their family members recruited from a 10 million inhabitant catchment area; 2) identify barriers that may hinder its feasibility and patient/family conditions that can render this type of treatment ineffective or inappropriate; 3) identify clinical, psychological, and environmental and service predictors of treatment effectiveness in FEP. Study participants will be recruited from Community Mental Health Centers (CMHCs) operating for the Italian National Health Service and located in several Northern and Central Regions of Italy. The GET UP PIANO Trial has a pragmatic cluster randomized controlled design, which is considered the gold standard approach for trials that evaluate complex interventions implemented at the institutional level, with the aim of improving health. The assignment units (clusters) are the CMHCs, and the units of observation and analysis are the Centers' patients and their family members. Patients in the experimental group will receive TAU plus: (a) Cognitive-Behavioural Therapy (CBT) sessions, (b) psycho-educational sessions for family members, and c) a case manager, to serve as the patient's referent. Patient enrollment will take place over a 1 year interval, after a 3 month-long piloting. The fidelity of the experimental interventions and the characteristics of TAU will be regularly monitored. Several psychopathological, psychological, functioning and service use variables will be assessed at baseline and 9 month follow-up by independent evaluators. Assuming an expected incidence rate of 17/100.000 per year for functional psychoses (as previously estimated in Italy), the investigators expect to recruit about 800 patients, and 600 relatives. Assuming an attrition rate of about 50%, the size of the trial would detect at 9 months a difference in terms of primary outcome from 25% for the TAU arm to 10% for the intervention arm, with a power of 80%.
The situation in Italy regarding radiation dose to patients undergoing Multidetector row Computed Tomography (MDCT) scans is unclear despite Italian law require that each centre check the Reference Dose Level (RDL) every two years. RDL in CT were first suggested in a document of 1998 published by the European Commission (EUR16262/1998) based on the results of an older survey in the UK from the late 1980s. Those RDLs, expressed in terms of Computed Tomography Dose Index (CTDI) and Dose Length Product (DLP), are reported in the Italian law (D.Lgs.187/00). However, in Italy there is no governmental authority comparable to the UK's National Radiological Protection Board, deputed to dose evaluation and protection. An overview of the Italian situation is relevant in order to know the actual dose levels for MDCT administered to patients both adults and paediatrics.
Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.
Aims of the study: This is a randomized-controlled trial to test the effects of robot-assisted gait training on locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait impairments. The control group will be treat with conventional physical therapy. Subjects and methods: 60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics. Informed consent will be obtained. Participants will be randomized to Robot-assisted gait training (experimental group) or conventional therapy (control group) through a randomization stratification approach, according to a block randomization of 4. The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2 sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks (2 sessions/week), that will focus on gait training. Primary outcome measures will be both neurophysiological measures (motor unit firing rate characteristics) and clinical test for gait speed (10m walking test). Secondary outcome measures will include: clinical tests of walking endurance (six minute walking test), balance (Berg Balance Test) and mobility (Up and Go Test). Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored. Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale. Outcome measures will be assessed the week prior to treatment initiation (T0), after 6 sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.
The purpose of this study is: - To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. - To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. - To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment
The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.
This study will assess safety as well as establish a Recommended Phase II dose of the combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F mutation who have been diagnosed with primary myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).
Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity and influence Survival in Colorectal Cancer Patients
Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders, with a high impact on disability and participation. Poor adherence to pharmacotherapy negatively impacts on the course and outcome of PSS. Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of relapse and readmission up to 5-time higher than in adherent patients. Falloon et al. developed a Psychoeducation Program (FPP) aimed at improving communication and problem-solving abilities in patients and their families. Past studies reported a statistically significant reduction of the risk of relapse in patients receiving the FPP, but did not take into account effects on adherence. Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another group exposed to a treatment with generic informative prospects on the disorders provided with same attendance frequency as the FPP (Generic Treatment - GT). Methods: 340 patients with PSS, from 10 participating units distributed in the territory of the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and concurrently with the administration of a 4-item interview, based on a modified version of the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method, followed by Log-rank test, defining as terminal events both the start of non-adherence and/or the first relapse or readmission episode. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate missing data. Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already in contact with a psychiatric service is 47%; effect size of psychosocial treatment on various outcomes, including relapse, readmission and adherence to drug is 0.48 of the standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce a change in the prevalence of non-adherence to drug in the exposed group with an effect size of 0.45 SD.