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.
Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Based on the current evidence, the role of OIN appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. Regarding not malnourished patients, there is still no clear correlation between OIN and decrease in post-operative complications. Furthermore, whether OIN increases immune response within the tumour microenvironment is based on studies with poor number of patients.
The study is observational, longitudinal, retrospective and prospective, on patients with PV. Patients with PV diagnosed from 2000 to 2023 according to WHO2017 criteria will be considered. The main purpose of the study is to determine the impact of clinical and laboratory characteristics of Polycythemia Vera on patients' prognosis, understood as long-term survival
The goal of this retrospective multicenter observational study is to understand and evaluate the diagnostic and therapeutic management of pure forms of Florid Lobular Carcinoma In Situ (FLCIS) and Pleomorphic Lobular Carcinoma In Situ (PLCIS) of the breast. It addresses the significant challenges and controversies surrounding their clinical management, due to a lack of consensus or approved international guidelines. The main questions this study aims to answer are: - How is the diagnostic process for pure FLCIS and PLCIS currently managed? - What are the primary therapeutic approaches for these specific breast conditions? - How are positive and "close" surgical excision margins handled? - Is adjuvant treatment, such as hormone therapy and radiotherapy, necessary? - What factors are associated with recurrences? - What are the rates of recurrences and/or upgrade to invasive carcinoma? Participants will retrospectively collect all cases of pure FLCIS and PLCIS, reporting detailed data about their diagnostic and therapeutic management, as well as clinical and survival outcomes. Methodology: This international multicenter retrospective study will collect cases involving the pure forms of FLCIS and PLCIS of the breast. The study aims to provide insights into the current diagnostic and therapeutic approaches, along with the identification of opportunities to enhance clinical management, ultimately providing evidence-based recommendations and addressing the current lack of scientific literature regarding their treatment.
The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that sacituzumab tirumotecan is superior to TPC with respect to OS.
This study aims to evaluate the patients'quality of life before and after surgery for vulvar cancer and reconstruction, employing different questionnaires and investigating different items.
The aim of the study is to evaluate the efficacy of the co-created, culture-sensitive intervention to promote healthy diet, physical activity, and to improve compliance to therapeutic protocols in immigrants with type 2 diabetes.
Patients belonging to Group 1 (Major Depression) and 2 (Bipolar Disorder) will be tested with psychometric and functional scales at baseline (T0) and after 4 weeks of pharmacological therapy (T1), to evaluate clinical and functional response to treatment. MDD patients will be screened for the lifetime and recent occurrence of clinically meaningful suicidal ideation and behavior prior to recruitment (-T1). Moreover, in the MDD group, the emergence of clinically meaningful suicidal ideation and behavior will be evaluated at the baseline (T0) and after 4 weeks (T1) by means of the C-SSRS, accordingly to the routine clinical practice. Furtherly, to accomplish the pursues of this research, the two groups will undergo neuroimaging evaluation and a blood collection at the two timepoints for measuring the expression of ncRNA before and after treatment. Meanwhile, a lumbar puncture (LP) for CSF collection will be carried out at the baseline, measuring central levels of Negr-1 and other biomarkers of neurotropism potentially related to the aforementioned role of Negr1 in MDD. Group 3 will be comprehensive of 10 subjects without current or previous diagnosis of psychiatric disorders (healthy controls), who will be evaluated at baseline with psychometric and functional scales, neuroimaging and blood samples collection for ncRNA. Data obtained by the multimodal assessment of HCs at the baseline will be employed as normalization features in the statistical analysis of patients' data.
To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation creating a predictive model for related complications after kidney and liver transplantation based on the pre-operative and post-operative levels of MR-proADM and by a machine learning process.
The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).
Patients presenting with a de novo diagnosis of luminal-like advanced breast cancer (ABC) or with disease recurrence after >12 months from the end of adjuvant ET, are generally candidate to a first line therapy with an aromatase inhibitor in association with a CDK4/6i. Disease recurrence in <12 months from the end of adjuvant ET defines the disease as "endocrine resistant" and identifies patients that should receive a first line therapy with the selective estrogen receptor degrader (SERD) Fulvestrant in association with the CDK4/6i Ribociclib, according to the results of the MONALEESA-3 trial. A significant percentage of ABC patients develops a primary resistance with disease progression within the first 6 months from the beginning of the treatment. Furthermore, another relevant percentage of patients initially responding to the therapy, will later develop a secondary resistance, thus progressing after a median of 2 years from the beginning of the treatment. Thereby, it is crucial to identify biomarkers that could be predictive of a response or a resistance to ET and/or CDK4/6i, to provide the best therapeutic strategy, tailored upon both clinico-pathological and molecular characteristics. Numerous pathways associated with resistance to CDK4/6i have been investigated by means of liquid biopsy analysis. The aim of this study is to identify potential biomarkers predictive of a clinical benefit in patients receiving a first line therapy with AI/fulvestrant (+/- LH-RH analogue) in association with a CDK4/6i for luminal-like advanced breast cancer.