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.
RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.
People with migraine typically show impaired responsivity to visual, auditory and pain stimuli (Burstein et al, 2015). The electrophysiological study of the nociceptive blink reflex (nBR) is widely adopted for the instrumental evaluation of trigeminal afferent function. Migraine sufferers characteristically show deficits in the habituation to repeated stimulations of various sensory modalities, in the interictal phase of the disease (Bohotin et al, 2002; Di Clemente et al, 2005). It has been described how the habituation / sensitization pattern presents a characteristic pattern over the course of the migraine cycle. Past evidence suggests that the habituation deficit may turn towards a normalization of the pattern near the acute migraine attack (Coppola et al, 2013; Katsarava et al, 2003). However, the study of the spontaneous attack shows various limits and difficulties, mainly due to the impossibility of predicting the onset of the next attack and of standardizing the experimental conditions. The use of human models of migraine allows us to overcome these obstacles. Di Clemente et al. (2009) evaluated the electrophysiological changes in nBR after administration of nitroglycerin (NTG) in healthy subjects. The authors described a modification of trigeminal circuits and cortical responses (visual evoked potentials) after NTG. However, NTG administration does not induce migraine attack in healthy subjects, therefore this model cannot be directly translated to migraine pathology (Ashina et al. 2017). Our group has previously used the human model of migraine based on the administration of NTG to study central and spinal level sensitization through the nociceptive avoidance reflex in the lower limb (RIII) (De Icco et al. 2020). The results of the previous study deepened our understanding of the central mechanisms of sensitization. The investigation of the nBR allows to study the modulation of the caudal trigeminal complex (TCC). In the present study we therefore intend to evaluate, under well-controlled experimental conditions, the modulation of the trigeminal caudal complex during an experimentally induced migraine attack. The study will allow us to confirm or not the normalization of habituation described in the acute phase through the adoption of a solid cross-over and placebo-controlled study design.
BOUNCE is an international multicentre randomised phase II trial. The trial treatment consists of brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease. The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation, compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression.
This study will compare the effect of HFNC versus standard oxygen administration after elective esophagectomy for cancer.
The use of ultrasound has been suggested to support the management of labour. According to several studies, ultrasound examination is more accurate and reproducible than clinical examination in diagnosing fetal head position, fetal station, and the prediction of labour arrest. Furthermore, there is growing evidence that ultrasound in labour may predict the outcome of instrumental vaginal delivery: a support to assess when an operative delivery is necessary. Ultrasound in labour can be performed using a transabdominal approach, mainly to determine head and spine position, or a transperineal approach, to assess head station and the situation at low stations. Several sonographic parameters have been proposed to evaluate the head station. Furthermore, all ultrasound parameters studied so far, have always been measured with the woman in a supine position. While the biomechanics of childbirth with its mechanisms (known as nutation, counter-nutation of the pelvis, and the coccyx retropulsion) together with maternal movement, promote fetal rotation and the adaptation of its diameters with those of the maternal pelvis, allowing to gain more room for the fetal descent. Moreover, in most of the studies on intrapartum ultrasound, the mobility of the pelvis has not been mentioned. The contracted pelvis is the absence of mobility that leads to fetal-pelvic disproportion, arrest of labour, and operative delivery. Maternal pelvis biomechanics studies by high technological techniques have shown that maternal shifting positions during pregnancy and childbirth can create more room in the pelvis for safe delivery. The external and internal pelvic diameters are closely related. For this reason, the evaluation of the mobility of the pelvis appears to be a necessary element to understand the ability of that pelvis to widen its diameters for fetal descent. The aim of the study is to measure the variation of AoP, HSD, HPD, PAA in the supine position and in kneeling-squat position in the same woman and the cut-offs of the new ultrasound parameters and predictive capacity for vaginal birth.
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.
This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.
The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.
Population Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) therapy for ≥3 months, naïve to biological (b) and targeted synthetic (ts)DMARDs therapy and a maximum of 2 swollen joints (out of 44 joints) Study design Randomised multicentre, parallel-arm clinical study Primary objective Non-inferiority of the experimental arm (i.e. clinical therapy together with ultrasound guided treatment decision) in comparison to the control arm (clinically guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case starting from high disease activity and achieving low disease activity) or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24. Intervention This is a randomised multicentre, national, parallel-arm clinical study. Patients with a diagnosis of RA, moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) therapy for ≥3 months, naïve to biological (b) and targeted synthetic (ts)DMARDs therapy and a maximum of 2 swollen joints (out of 44 joints) will be included and randomized to one of the following two strategic arms: 1. Clinical decision strategy: All patients receive a TNF-alpha blocker while continuing background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator. 2. Clinical plus ultrasound-based decision strategy. All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a TNF-alpha blocker while continuing background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background csDMARD(s) will be continued. Sample size 110 patients Time plan - Total duration of the study: 42 months - Active phase for each patient: 48 weeks (24 weeks for the interventional treatment strategy and 24 weeks for follow-up visit) - Recruitment: 30 months
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.