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 gap between patients awaiting and those undergoing liver transplantation (LT) continues to grow. Marginal organs carry higher risk of failure after LT however they are increasingly used to fill such gap. Viability assessment of the graft is essential to lower the risk of LT failure and need for emergency re-LT, however this still relies mainly on surgeon's experience. Post-LT graft function recovery assessment is also essential to aid physicians in the management of LT recipients and guide them through challenging decision-making. With the present study we aim to validate the use of indocyanine green clearance test (IGT) in two settings: in the donor as an objective tool to assess graft viability; in the recipient to assess graft function recovery after LT. The implementation of IGT in routine practice translates into two main advantages: to avoid using grafts with no chance of recovery and to optimize resource allocation to LT recipients depending on their graft function recovery.
Sleep is regulated by the interaction of homeostatic and circadian processes. The homeostatic process determines sleep propensity in relation to sleep-wake history, the circadian one is responsible for the alternation of high/low sleep propensity in relation to dark/light cues, and is substantially independent of preceding sleep-wake behaviour. The circadian timing system encompasses a master clock in the brain and peripheral, ancillary time-keepers in virtually every organ of the body. In recent years, evidence has emerged that circadian disruption has serious medical consequences, including sleep loss, increased cardiovascular morbidity and increased risk of certain types of cancer. Evidence is also emerging that hospitalization per se weakens circadian rhythmicity, due to disease itself and to modified light, food and activity cues. The aim of our project is to test an inpatient management system (CircadianCare) that limits the circadian impact of hospitalisation by enhancing circadian rhythmicity through an assessment of the patient's specific circadian features/needs and an ad hoc, personalized light-dark, meal and activity schedule to cover the whole of the inpatient stay. This will be compared to standard inpatient management in terms of patients' perception, sleep-wake quality and timing during hospitalisation, inpatient utilization of sleep-inducing medication, length of hospitalisation, and prognosis (i.e. outcome of hospitalisation, subsequent hospitalisations and post-discharge sleep-wake disturbances). The CircadianCare system is expected to benefit prognosis, decrease costs, and change the way hospitals are organized and designed in future, with potential direct relevance to the plans for the new University Hospital of Padova.
This trial involves patients with hepatocellular carcinoma (HCC) diagnosis treated with transarterial radioembolization (TARE) with resin microspheres loaded with 90Y. Patients will be divided in two groups based on prescription method to calculate the therapeutic radionuclide activity to be injected. In arm A, standard dosimetric approach such as Body Surface Area (BSA) method and Medical Internal Radiation Dosimetry (MIRD) monocompartmental method will be used. In arm B, novel voxel-based dosimetry, based on pre-treatment simulation with 99m-Technetium (99mTc)-Macro Aggregated Albumin (MAA) injection and SPECT/CT image acquisition, will be used. The primary outcome will be the overall survival of patients included in arm A and arm B. Secondary outcomes will be adverse events, tumor response, biomarkers assessed from blood samples prior and after the treatment and voxel-based dosimetry obtained from post-treatment PET/CT images acquisitions.
A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.
To prospectively study the effect of adherence to ERAS and PBM programs on early outcomes after colorectal surgery
INTRODUCTION: It is very common that migraine patients could refer neck pain during or after the pain phase of migraine, suggesting that migraine pathophysiological mechanisms could be effective in activating neck pain pathways and be part of the migraine attack. Due to the therapeutic effect of multimodal physical therapy (mobilization and/or manipulation plus exercises) on several pain conditions arising from articular and/or muscular structures such as neck pain, and given the close clinical, anatomical and pathogenetic bi-directional relationship between neck pain and migraine, it would be of interest to evaluate the effectiveness of the physical treatment of the neck region in migraine pain. PURPOSE: to evaluate the efficacy of a combined multimodal physical therapy approach plus usual care vs. usual care alone in subjects with episodic and chronic migraine with concomitant cervical musculoskeletal dysfunctions. STUDY DESIGN: this is a prospective, parallel group, randomized clinical trial. METHODS: A total of 56 subjects aged 18-65 who meet criteria for episodic or chronic migraine with concomitant cervical musculoskeletal dysfunctions will be randomly assigned to receive, musculoskeletal focused multimodal physical therapy (16 sessions over 8 weeks) plus usual care treatment vs. usual care alone. CONFLICT OF INTEREST: not declared.
Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).
The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and childhood myotonic dystrophy type 1, and develop biomarkers for the condition.
Advanced Endovascular repair of aneurysms and dissections involving thoraco-abdominal (type I-IV) and complex abdominal (juxta and para-renal) aorta is a ground-gaining procedure allowing favorable results in high surgical risk patients. The availability of iliac vessels navigation and the major role of lower leg perfusion in order to decrease the risk of spinal cord ischemia during these complex procedures, led to the development of devices with lower sheaths sizes and to the improvement of the technique with preloaded devices for visceral vessels in order to navigate in hostile anatomies or when an iliac access is not available. The aim of the study is to evaluate in a prospective single center observational setting, the outcomes, safety and efficacy of the modified preloaded system for renal arteries in fenestrated endografting in the routine treatment of paravisceral and thoraco-abdominal aortic pathologies.