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.
The goal of this clinical trial is to evaluate the efficacy of an artistic tool, the mandala, in a population of pregnant women (nulliparous) undergoing labor induction. The main questions it aims to answer are: - Does using the mandala during labor induction improve the birth experience? - Does the use of the mandala during the induction of labor improve the outcome of the birth and the demand for analgesia? Participants in the intervention group will receive standard treatment plus coloring mandala, those in the control group only standard treatment.
Inguinal hernia repair is a common surgical procedure done as day surgery. Because patients need to be discharged on the same day, the choice of anesthesia technique is influenced. One option is the ilioinguinal (II)-iliohypogastric (IH) nerve block, a type of transversus abdominis plane (TAP) block, which has benefits such as faster recovery, better pain control, and reduced opioid use. It also allows for quick discharge, early feeding, and no need for post-anesthesia or recovery unit stay. This study aims to evaluate the success of the II-IH nerve block as the preferred anesthesia strategy for patients undergoing unilateral inguinal hernia repair using the Lichtenstein technique. The study will analyze various factors such as BMI, age, optimal ultrasound vision, amount of anesthesia used, dose of anesthesia administered, time between block execution and incision, and sedative dose needed to determine independent variables of block effectiveness. The study will include patients aged 18 or older, with ASA I-II-III classification, and who provide informed consent. Patients with allergies to local anesthetics, certain medical conditions, obesity, difficulty visualizing target structures, non-cooperative behavior, or taking anticoagulant therapy will be excluded. The study will be conducted at the Sant'Antonio Hospital (Padova University Hospital) operating rooms for one year, aiming to recruit around 400 patients. Informed consent for data processing will be obtained during the preoperative anesthesia visit, and standard anesthesia procedures will be followed during the surgery. As usual care the patient will be monitored before surgery using an electrocardiogram, oxygen saturation measurement, and non-invasive blood pressure. After adequate sedation, the II-IH nerve block will be performed under sterile conditions and ultrasound guidance. Participation in the study does not modify the commonly used anesthesia procedures and does not pose any additional risks or provide direct benefits to the patients. The data collected will be treated confidentially and used exclusively for the study's purposes. Data collection will be conducted through a paper-based form, and only a few variables will be recorded. The study's findings will be made public, even if negative, and will be submitted to the ethics committee within twelve months of data collection completion.
The goal of this prospective observational study is to generate new personalised 3D preclinical models of pancreatic neuroendocrine tumors. The models will be exploited for studying the mechanisms underlying disease development and progression, as well as for performing drug testing. For the development of the newly proposed models, patients' surgical specimens will be evaluated by the Pathological Unit. If the presence of pathological material in excess, not required for the routine diagnostic procedure, is confirmed, such material will be employed for the generation of the proposed personalised models.
The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
The goal of this observational study is to learn about endothelial damage in major spine surgery, expressed as rise in circulating Syndecan-1. The main questions it aims to answer are: - What is the extent of endothelial glycocalyx shedding in major spine surgery? - Are there differences in different type of surgical populations? (adolescent idiopathic scoliosis, adult degenerative spine disease, oncologic surgery) To do so, blood samples will be drawn from participants at the following timepoints: - basal - after surgery - if transfusion of Fresh Frozen Plasma: before and after transfusion - Post-Operative Day 1-2-4
The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy/tolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP). In particular, the aims of the study will be: - primary aim: to investigate the relationships (if any) between plasma concentrations and activity/toxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers; - secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy). The study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.
The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment. Study details include: - The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period. - All participants who complete the 16-week DBT period will be offered entry into an optional LTE. - Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period. - The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.