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.
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges
This study protocol describes the design and methods of the PanCareSurPass (PCSP) multi-country implementation study of the Survivorship Passport v2.0 (short: PCSP implementation study), which is part of the PCSP project that has received funding through the European Union (EU) Horizon 2020 Programme. The cohort study will inform researchers and stakeholders on the process and outcomes of implementing the Survivorship Passport (SurPass) v2.0 in the Electronic Health Information Systems (EHIS) of six clinics in the EU countries Austria (CCRI), Belgium (KU Leuven), Germany (UMC-Mainz/UzL), Italy (IGG), Lithuania (VULSK) and Spain (HULAFE). The SurPass comprises two main components, the Treatment Summary (TS) including demographic, diagnosis and treatment data and the personalized Survivorship Care Plan (SCP) including individual follow-up care recommendations. The SCP is based on internationally approved, organ-specific follow-up care recommendations. The SurPass is used as a tool to assist both Childhood Cancer Survivors (CCS) and Health Care Providers (HCPs) to improve Long-Term Follow-Up (LTFU) care, in a care partnership, supporting CCS empowerment and satisfaction with care, as well as shared decision-making by CCS and HCPs. People-centred care is important in CCS since they are a vulnerable population known to be at higher risk of developing chronic conditions as compared to their peers in the general population. The overall aim of the cohort study is to evaluate the implementation of the SurPass v2.0 in the six centres by testing the feasibility of test wise implementation of the SurPass v2.0 in different health system scenarios and assessing the people-centred LTFU care for CCS with the SurPass as a tool and the cost effectiveness. Six long term follow-up clinics across Europe will enrol eligible, consented CCS and generate personalised digital SurPass. Eligible participants for the main study cohort will be CCS more than 5 years after diagnosis and with an identified treatment burden based on actual exposure to respective treatments (Cumulative Treatment Doses (CTD) of chemotherapy, immunotherapy, radiotherapy). In preparation of the clinic visit, HCPs/local data monitors will use the SurPass v2.0 platform to generate the TS (semi-automated or manual data entry) from which, in turn, the preliminary SCP is automatically created using the built-in algorithms for each consented survivor. During the clinic visit the preliminary SCP is discussed with the Survivor, and tailored to meet the CCS personal needs and a final SCP will be generated. The SCP will include detailed country-specific recommendations, where applicable. The SurPass v2.0 (TS + SCP) will then be integrated into the institutional EHIS, as well as in the survivor's national/regional Electronic Health Platform (EHP) where available. CCS who give informed consent will complete (online) study questionnaires at two measuring points: before the visit to the clinic, and after they received the SurPass during the clinical visit. HCPs will also provide study data: the TS which went into the SurPass (clinical data) and data to monitor the implementation and assess the barriers and facilitators of implementing the SurPass. In addition, data will be collected from both survivors and health care providers to assess the cost-effectiveness of implementing the SurPass. Regarding the outcome evaluation, the main outcome is the change in levels of activation of survivor or caregiver, as assessed using the Patient Activation Measure (PAM) prior and after clinic visit. Further measurements will be made related to: empowerment, satisfaction with the digital SurPass tool, emotional impacts, quality of life and additional costs of CCS. The main outcome will be analysed by multivariable logistic regression. Analysis for the secondary outcomes will be mostly descriptive. The economic assessment will be analysed by cost analysis, cost utility analysis and multi-criteria decision analysis. The study will be conducted in accordance with the guidelines of good clinical practice (ICH/GCP) and the Helsinki Declaration. The investigators will carefully address all ethical, legal and safety aspects of the study and fully comply with prevailing national and EU regulations and legislation.
This is a parallel monocentric, retrospective cohort study in Guglielmo da Saliceto Hospital, Piacenza, Italy. Aim of this study is to investigate the protective role of Indocyanine green (ICG) for Anastomotic leak (AL) in patients underwent elective segmentary colic resection (transverse colic resection, left colectomy including sigmoidectomy, splenic colic flexure resection). Secondary aims are to detect and to investigate the impact of various risk factors on AL and morbidity and surgical performance within 30 days to surgery.
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026 or CN012-0027. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 or CN012-0027 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years. This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).
The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
The FOOD-AUT pilot study aimed to improve the health status of adults with Autism Spectrum Disorder (ASD) through a nutritional intervention at canteen service. The researchers adapted the canteen menus to the nutritional and sensory needs of this vulnerable population, reducing their food selectivity and improving their dietary diversity with a positive impact on their health. This project consisted of two phases: first an observational phase (Work Package 1, WP1) and secondarily an interventional phase (Work Package 2, WP2).
The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of DME. This study will assess adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting. Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally. Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers. Only one eye per participant will be evaluated in the study. No additional burden for participants in this trial is expected.
The goal of this randomized clinical trial is to compare the efficacy of the use of a diary to record behavioral and psychological symptoms of dementia (BPSD) in persons with dementia. The main questions it aims to answer are: - Does the use of a diary lead to a reduction of the caregiver's burden at 3 months, compared with standard care? - Does the use of a diary lead to a reduction of the neuropsychiatric inventory (NPI) score at 3 months, compared with standard care? - Does the use of a diary result in less psychotropic drugs prescribed to the patient at 3 months compared with standard care? - Are physicians and caregivers satisfied with managing patients with the use of a diary? - Does the use of a diary reduce the caregiver's stress related to BPSD at 3 months, compared with standard care? Participants will be randomly assigned to either the use of a diary or a control group. Caregivers in the diary arm will be asked to fill in a diary with BPSD including triggers, severity, day and hour, to be analyzed by physicians to prescribe appropriate pharmacological or non-pharmacological interventions. The control group will receive usual care (i.e., appropriate interventions will be applied after interviewing the caregiver and/or visiting the patient).