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.
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).
In this single-center, prospective, randomized, open label, phase-III study, patients with indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive the suppositories ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering International Prostate Symptom Score (IPSS) with Quality of Life (QoL) questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.
Patients affected by schizophrenia often present significant deficits in various aspects of social cognition, such as social perception, recognition of one's own and other people's emotional state and the theory of mind. Recent studies investigated the correlation between social cognition and real-life functioning, reporting that greater social cognition deficits determine worse social and occupational functioning in real-life. Therefore, social cognition deficits represent an important target both in therapeutic and rehabilitative treatment in patients with psychotic conditions, especially in the early phases of the disease. Our research group has implemented a new individualized rehabilitation programme for social cognition: the Social Cognition Individualized Activities Lab, SoCIAL. The pivotal study showed that this programme improves specifically social cognition abilities, even when compared to a standardised and validated rehabilitation programme such as the Social Skills And Neurocognitive Individualized Training (SSANIT). However, the improvement in social cognition did not translate in improvement in real-life functioning. Recently, another key aspect that plays a role in quality of life and real life functioning in people with schizophrenia has emerged, the narrative abilities. Available data confirm that this variable has a strong impact on social functioning and quality of life in patients with schizophrenia. Taking into account the above evidence, our group decided to implement a new version of the social cognitive remediation programme in order to overcome the limitations found during its pivotal study. The new SoCIAL programme is characterized by specific modules for training of social cognition and narrative abilities in patients with schizophrenia. The efficacy of this programme, compared to treatment as usual, in individuals diagnosed with schizophrenia or schizoaffective disorder will be assessed. The generalization of improvement to real-life functioning domains will also be evaluated in completers and in the intent-to-treat sample.
The present clinical study aims to verify the effectiveness and safety of the blue light photobiomodulation therapy with EmoLED medical device in supporting the reparative process of the area of the second and third stage decubitus lesion, comparing this method with the effectiveness of the therapy commonly used in the clinical field.
The study will collect use data of the Becton Dickinson (BD) PureHub™ Disinfecting Cap in combination with needle-free connectors, which are attached to vascular access devices (VAD).
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.
The prevalence of common mental disorders is high in patients with chronic inflammatory physical diseases(e.g., autoimmune or infectious diseases). The traditional explanatory causation model in which physical symptoms and related disability drive mental health problems is now called into question, and evidence has accumulated supporting more complex interactions whereby psychiatric disorders can both result from and contribute to the progression of physical diseases. In the present project, the investigators will focus on comorbidity of depression and anxiety symptoms or syndromes with chronic inflammatory skin diseases (psoriasis, hidradenitis suppurativa and atopic dermatitis) or chronic infectious diseases (chronic HBV and HIV infection). The study is aimed to clarify the mechanisms underlying the high frequency of those comorbidities. It will overcome the main limitations of previous investigations and use innovative statistical tools to model complex interrelationships and causal links among the assessed variables. The identification of key variables driving the causal chain of determinants of poor global health and quality of life may impact treatment outcome and models of care.
Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.
Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.
Kidney biopsy (KB) is an invasive procedure that is very useful in diagnosing kidney disease in both the native kidney and the transplanted kidney. Patients undergo KB can feel anxiety and pain. Pain is considered one of the worst experiences for patients and anxiety affects the sympathetic nervous system, the endocrine system and the immune system. The aim of this preliminary study was to evaluate the influence of MTI as a complementary/nonpharmacological intervention on heart rate variability, anxiety and pain and promote more compliant behaviours during KB.