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.
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).
This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.
The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in patients undergoing de novo PV isolation (PVI) for treatment of paroxysmal atrial fibrillation (PAF).
Although some surgeons still consider bilateral neck exploration as the best approach for primary hyperparathyroidism, nowadays most of them perceive the mini-invasive parathyroidectomy (MIP) as the best option for patients with concordant preoperative studies. Nevertheless, the consensus is heterogeneous for patients with unclear localisation studies, with some surgeons deeming BNE as mandatory and others suggesting that a mini-invasive approach is still possible if combined with IOPTH monitoring. In our research, we focused on patients with unclear preoperative localisation studies, to better understand the factors that can determine discordant or negative results between US and MIBI scan, in order to choose the best surgical approach and to evaluate the outcomes in this kind of patients.
Intraoperative protective ventilation with low tidal volumes (TV), positive end-expiratory pressure (PEEP) and possibly lung recruitment maneuvers (RMs) reduces postoperative pulmonary complications. In thoracic surgery, in one-lung ventilation (OLV), the evidence is lacking. However, in this context protective ventilation with PEEP titration is related to better intraoperative oxygenation and respiratory mechanics. It is not clear whether this strategy is associated also with better postoperative oxygenation and less postoperative pulmonary complications.
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Aim of this study: is to evaluate the influence of stress level on the response of non surgical periodontal therapy in patients affected by severe periodontitis divided into "Medium/High stress level" or "Low stress level" based on the Perceived Stress Scale (PSS). The defined primary outcome referring to the clinical response of the patients is the bleeding index, Full-Mouth Bleeding Score (FMBS), as a clinical sign of inflammation. Materials and Methods: Monocentric prospective triple blinded study. A single evaluator conducting all the psychologic tests, a single operator blinded to the results of the psychologic tests doing all the clinical measurements, and the patients will be initially blinded to the category of stress that they'll belong to. The minimum number of patients to enrol will be 89 based on a sample calculation. Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: Age from 20 to 80 years Diagnosis of Periodontitis stage III/IV according to the new classification (2018); Presence of at least 14 teeth, with a minimum of 10 sites with PD at least > 5 mm and radiographic evidence of alveolar bone loss. Written informed consent Exclusion Criteria. The presence of any of the following will exclude a subject from study enrollment: Smokers > 10 cig/die Patients with orthodontic appliances; Pregnant or lactating women; Individuals who have received periodontal treatment in the 6 months prior to recruitment; Patients with systemic diseases that could interfere the clinical response to periodontal treatment (i.e. diabetes); Subjects under treatment with antibiotics, steroidal and/or non-steroidal anti-inflammatory medication 3 weeks prior to the visit and patients treated with antiepileptic drugs Operative procedure: Clinical parameters and psychologic test will be done at the baseline. All the patients will be treated by means of non surgical periodontal therapy on a quadrant protocol including oral hygiene instructions and motivations and subgingival instrumentation in four successive visits. 6 weeks after the last visit, the clinical parameters will be registered again. Clinical Parameters: Periodontal condition of each patient will be evaluated through the collection of the following parameters: - Full-Mouth Bleeding score (FMBS): presence/absence of bleeding on probing using a periodontal probe on each surface of the tooth (six sites per tooth), calculated in percentage for all the examined teeth. - Full-Mouth Plaque Score (FMPS): presence/absence of plaque using a periodontal probe on each surface of the tooth (six sites per tooth), calculated in percentage for all the examined teeth. - Probing Depth (PD): measured for each surface of the tooth (six sites per tooth) using a periodontal probe, measured as the distance between the cementoenamel junction (CEJ) and the depth of the pocket. - Gingival recession (Rec): measured for each surface of the tooth (six sites per tooth) using a periodontal probe, measured as the distance between the cementoenamel junction (CEJ) and the free gingival margin. - Clinical attachment level (CAL): The sum of PD and Rec. Psychologic Test: The Stress condition of each patient will be assessed by a Psychologist using: PSS is a 10-items self-report questionnaire that measure the degree to which situations in one's life are appraised as stressful. The PSS is scored on a 5-point scale (never, almost never, sometimes, fairly often and very often). PSS norms are available from a sample of the USA collected by Cohen & Williamson (1988). The mean level for men was 12.1 (S.D. 5.9) and for women 13.7 (S.D. 6.6).
Elderly individuals are increasingly represented among patients with acute coronary syndrome (ACS). Dual antiplatelet therapy (DAPT) with aspirin and an oral P2Y12 receptor inhibitor has an established role in the prevention of atherothrombotic events in ACS setting. However, DAPT in older patients is challenged by a concurrent heightened risk of ischemia and bleeding. Although guidelines recommend DAPT with aspirin and ticagrelor for elderly patients with ACS, clopidogrel, a less potent antiplatelet agent, continues to be used in more than one third of ACS patients with elderly status being the strongest predictor of undertreatment. A lower dose of ticagrelor may represent an alternative to the standard dose by conferring a similar efficacy and, potentially, a better safety profile. Our prospective, randomized, double-blind, crossover trial will test the hypothesis that a lower dose of ticagrelor provides similar antiplatelet effects compared with a standard dose among elderly patients with ACS. The main aim of the trial is to determine the pharmacodynamic and pharmacokinetic profile of ticagrelor 60 mg twice daily versus ticagrelor 90 mg twice daily among elderly patients with ACS undergoing PCI. This will be a prospective, randomized (1:1 ratio), non-inferiority, open-label, crossover trial to evaluate the level of platelet inhibition achieved with a low-dose of ticagrelor (60 mg twice daily) versus a standard dose of ticagrelor (90 mg twice daily) among elderly patients with ACS undergoing PCI.
We conducted a randomized-controlled trial of Guided Written Disclosure Protocol for dermatological patients with the aim of reducing psychological distress, expressive suppression, and skin-related symptoms, and improving spiritual well-being, cognitive reappraisal, and sense of coherence.