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.
A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment. To gain early insights on the use of T-DXd outside of a trial setting, patients with advanced/metastatic HER2+ breast cancer receiving treatment (or previously treated) with T-DXd through the NPP will be invited to participate.
Consecutive adult (>18 years old) subjects who tested positive for SARS-CoV-2 with nasopharyngeal swab at the local COVID-19 Prevention Centre were included. Patients were divided into two groups: cases (who performed nasal lavages) and controls (who did not perform lavages), with similar confounding factors (age, comorbidities, vaccination status). At the moment of diagnosis, patients were asked to fill out an ad hoc questionnaire to evaluate their symptoms at the moment of diagnosis and of negativization. Subjects were asked to perform, at a daily time of their choice, a nasal swab provided at the moment of enrolment. When the subjects tested negative for the first time, they had to complete the questionnaire once again. The study was divided into two phases. In the first phase cases were recruited and were given nasal washes (Tonimer Panthexyl®) to be performed three times a day, and in any case after nasal swab. In the second phase controls were recruited and were asked to perform only daily nasal swabs. Symptoms course and time of negativization were analyzed. Statistic comparisons were made using Kaplan-Meier test. P values <0,05 were considered to be statistically significant.
The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with respect to objective response rate. - Cohort A: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy - Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy - Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi - Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy - Cohort E: Participants with relapsed or refractory FL after at least 2 prior systemic therapies and have no other available therapy - Cohort F: Participants with relapsed or refractory CLL after at least 2 prior systemic therapies and have no other available therapy The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR).
Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance. The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.
This is a clinical study consisting of a study arm to assess the performance of the theranostic software module (Research Use Only) of a CE marked (CE1936) UV-A medical device, C4V CHROMO4VIS™, in order to validate its use for theranostic-guided corneal cross-linking treatment of keratoconus and corneal ectasia. The study hypothesis is that theranostic-guided riboflavin/UV-A corneal cross-linking with the C4V CHROMO4VIS™ system is safe and can estimate treatment efficacy during operation, regardless of treatment protocol, i.e., either with or without epithelial removal.
The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will: - have their blood pressure, heart rate, temperature, height and weight measured - have blood and urine samples taken - have physical examinations - have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) - answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer - answer questions about how they are feeling, or have their parents or guardian's answer - answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.
Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.
The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.
The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).