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.
Mosaicism within an embryo is defined as the presence of two or more cell populations with different genotypes. Blastocysts classified as mosaic by Preimplamtation Genetic Testing for Aneuploidy (PGT-A) have been reported to implant less and miscarry more frequently than embryos classified as euploid. Because of the unknown impact of mosaicism on embryo development, these embryos are given low priority and are discarded for transfer. However, recent papers on the transfer of human embryos classified by PGT-A as mosaic suggest that embryos with a low fraction of abnormal cells resulting in viable, chromosomally normal ongoing pregnancies, and high-level mosaics resulting in fewer viable pregnancies, but so far none producing mosaic babies. The apparent presence of mosaicism in an embryo is used as a selection criteria for embryo transfer (ET), introducing a strong bias in terms of patient prognosis and embryo quality. Additionally, it is also possible that some embryos are incorrectly classified as "mosaic" due to technical variability derived from the processing of a uniform aneuploid embryo. The aims of this study is to provide evidences about the clinical significance of chromosomal mosaicism in PGT-A cycles by a prospective non-selection based methodology.
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).
Assess the degree of vascular involvement is crucial in the diagnostic and therapeutic work-up of pancreatic cancer. NCCN resectability classification is used to stratify patients (in resectable, borderline resectable and non resectable) and is based on contrast-enhanced CT scan images. Unfortunately evaluation of imaging tests may rely on some degree of subjective interpretation by observers implying a fundamental variation in patient's treatments and an irreproducibility of different center study results. This is a multicenter diagnostic study on interobserver agreement on the resectability of pancreatic cancer based upon NCCN criteria. The primary aim of the study will be the assessment of interobserver variability to define vascular invasion and resectability status on CT scans (according to the last version of the NCCN Classification). One hundred and thirty eight consecutive patients, able to produce an informed consent, from 18 years of age, with a non-metastatic pancreatic adenocarcinoma assessed by a contrast-enhanced high-quality CT scan will be enrolled. 69 CT scan studies provided by the centers involved (High volume for pancreatic surgery) will be randomly selected from a pool of 138 of the patients that meet the inclusion criteria. Each study will be independently reviewed by a senior radiologist and a senior surgeon of each center, blinded to patient's clinical history and CT scan report, using NCCN definition of respectability status. A CFR will be filled during the review and send to the study coordinator. The data will be than centrally analyzed to asses interobserver agreement The enrolment phase will last 6 months and the whole study will last 8 months.
The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.
In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge. Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in mortality, in myocardial infarctions, in stent thrombosis, and in complementary revascularizations. Rotational atherectomy is now part of therapeutic armamentarium of interventional cardiologists for the treatment of some complex calcified coronary lesions. Last recommendations of the European Society of Cardiology about revascularizations indicate that rotational atherectomy should be used for "the preparation of calcified or massive fibrotic lesions that cannot be crossed by a balloon or for an optimal dilatation before stenting". However, this technique is not frequently used and limited to high-volume PCI centers. Even though rotational atherectomy demonstrated an improvement in immediate success of complex lesions, the longterm reduction of cardiovascular events after active stenting has not been proved. In observational studies, the results are not consistent because of many selection biases that influence the choice of an angioplasty with rotational atherectomy device (calcifications, severity of the disease). Furthermore, this technique needs operators with a certain amount of experience. The fundamentals of an optimal use of rotational atherectomy remain to be defined (duration and speed of burr, anti-platelet treatments...).
MyPeBS is an international randomized, open-label, multicentric, study assessing the effectiveness of a risk-based breast cancer screening strategy (using clinical risk scores and polymorphisms) compared to standard screening (according to the current national guidelines in each participating country) in detecting stage 2 or higher breast cancers. Women will be differentially screened for 4 years and then, after an end-of-study mammogram, they will return to the routine screening practice. The main study endpoint will be measured at the end of the four years of intervention. Furthermore, follow up data will be collected for 15 years from study entry for evaluation of long-term cumulative breast cancer incidence and breast cancer-specific survival
The aim is to assess the efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis (experimental group: pharmacological prophylaxis + Mindfulness) against pharmacological prophylaxis only (control group) on the reduction of monthly headaches frequency (primary endpoint), symptomatic medications intake, inflammatory pattern, depression, anxiety, cutaneous allodynia, improving disability and quality of life (secondary endpoints). Moreover, other aims are to assess whether adding on Mindfulness-based therapy is also associated to a superior improvement of neuroimaging pattern among patients prescribed neuromodulators or antidepressants and to assess the cost-efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis. Mindfulness will be provided in small groups (5-7 patients each) by specifically trained therapists. The treatment consists in six 45 minutes weekly sessions in which one will work on meditation, acceptance and awareness. The program of control group will consist in education of patients, followed by pharmacological prophylaxis. Prophylaxis is prescribed based on patients' profile, such as previous failures, contraindications and so on by a neurologist with expertise in headache treatments. We expect that adding-on Mindfulness will determine a wider reduction of headaches frequency and improvement of secondary endpoints, and that disease cost reduction will support the cost-efficacy of Mindfulness. The study will be a Phase III; randomized, Open-Label; Monocentric study. Patients will be enrolled to detect a 20% difference between the two groups on the primary outcome (50% or more of headache reduction by 12 months). For each medication type and research arm 20 patients will be selected: thus 80 patients will be enrolled for neuroradiological investigation.
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale.
To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.