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NCT ID: NCT03585374 Completed - Clinical trials for Acute Traumatic Pain

Trauma Acute Pain Treatment With Methoxyflurane Vaporized (PENTHROX®): Efficacy and Safety Study (MEDITA)

MEDITA
Start date: February 8, 2018
Phase: Phase 3
Study type: Interventional

The prompt treatment of pain due to minor trauma is often an unmet need in both Emergency Room Department and Ambulance Rescue. Most of the available drugs are intravenously administered and such route of administration may account for delay in the pain relief onset. Methoxyflurane is an halogenated anesthetic, self-administered by the patient at sub-anesthetic dose through an easy to handle inhaler (Penthrox®). The efficacy and safety of Penthrox® in the treatment of acute traumatic pain will be investigated in an out-of-hospital and in hospital emergency medical care setting.

NCT ID: NCT03585270 Completed - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain

REACT
Start date: February 3, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.

NCT ID: NCT03584906 Completed - Gingival Recession Clinical Trials

Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

Start date: August 16, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity

NCT ID: NCT03584516 Terminated - Clinical trials for Chronic Graft-versus-host Disease

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Start date: January 17, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

NCT ID: NCT03584204 Recruiting - Liver Cirrhosis Clinical Trials

Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome

SLIM
Start date: January 1, 2018
Phase:
Study type: Observational

The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

NCT ID: NCT03583723 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Adaptive Radiotherapy in Locally Advanced Non-Small Cell Lung Cancer (LARTIA Trial)

LARTIA
Start date: November 2, 2012
Phase: N/A
Study type: Interventional

Anatomical change of tumor during radiotherapy contributes to target missing. However, in the case of tumor shrinkage, adaptation of volume could result in an increased incidence of recurrence in the area of target reduction. This study aims to investigate the incidence of failure of the adaptive approach in Locally Advanced Non-Small Cell Lung Cancer and, in particular, the risk for local recurrence in the area excluded after replanning.

NCT ID: NCT03583502 Completed - Clinical trials for Breast Milk Expression

Krill Oil Supplementation: Effects on Breast Milk Composition

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Docosahexaenoic acid (DHA) belongs to long-chain polyunsaturated fatty acids (LCPUFAs) category and is a major building block for neuronal and retinal membranes, playing a crucial role in brain and visual development within the first months of life. Due to the lack of enzymes for the synthesis of its precursors, neonates strictly rely on dietary intakes of DHA. Antarctic krill (Euphausia superba) is a small crustacean rich in phospholipid-bound DHA, which is highly bioavailable, but whether it is effective in increasing DHA excretion in breast milk (BM) has not been investigated yet. This study aims to evaluate whether maternal supplementation with krill oil during breastfeeding increases DHA contents in breast milk BM. Mothers of infants admitted to the Neonatal Intensive Care Unit will be enrolled in this open, randomized, controlled study and randomly allocated in 2 groups. Group 1 will receive an oral krill oil-based supplement providing 250 mg/day of DHA and 70 mg/day of EPA for 30 days, whereas group 2 serves as control. BM samples from both groups will be collected at baseline (T0) and day 30 (T1) and will undergo a qualitative analysis of LCPUFAs composition by gas chromatography/mass spectrometry.

NCT ID: NCT03583411 Completed - Clinical trials for Acute Coronary Syndrome

Platelets Count Alterations in Patients With Acute Coronary Syndrome

Start date: June 25, 2018
Phase:
Study type: Observational

Platelet count alterations (thrombocytopenia and thrombocytosis) are a common condition in patients hospitalised for acute coronary syndrome (ACS), both at disease onset and in the following recovery phase.1-3 Different factors can explain this phenomenon. Thrombocytopenia could be either due to neurohormonal activation and the inflammatory process following myocardial necrosis leading to increased macrophage activation with increased clearance of platelets, or to an immuno-modulated mechanism caused by the administration of antiaggregant/anticoagulant drugs (heparin, glycoprotein IIb/IIIa inhibitors, P2Y12 inhibitors). Even the invasive treatment of coronaropathy during hospitalization, with angioplasty and stent implantation procedures and/or the eventual implantation of temporary mechanical blood circulation assistant devices [aortic counterpulsation, Impella, ECMO (Extracorporeal Membrane Oxygenation)], could further favour the phenomenon.4 Vice versa, thrombocytosis occurring during ACS has a reactive origin, caused by increased IL-6 production which, in turn, leads to an increase in thrombopoietin formation in the liver, causing a consequent stimulatory activity on megakaryocytes.2 Different studies have demonstrated a significant correlation between platelets count disorders and patient outcome (survival during hospitalization and in the immediate follow-up).5-11 This association has, however, often been considered an epiphenomenon of the underlying pathology. Platelets count alterations are, indeed, usually consensual to other hemogram alterations (anaemia and neutropenia), an indication of a coexisting medullar insufficiency (thrombocytopenia) or other heterogenous diseases such as cancer, iron deficiency or immuno-modulated diseases, usually associated with an increase in comorbidity indexes.12 Those alterations, moreover, can usually influence changes to the therapeutic approach (reduction/suspension of recommended standard therapies) and further condition the prognosis.13 Since a few years, the investigators have been established a cardiac-haematological collaboration aiming at finding early alterations in platelets count or, more generally, in cell blood count (CBC), collegially evaluating those alterations with a cardiologist and a haematologist (even in mild cases) and scheduling, on the basis of the aforementioned evaluations, a more precise and tailored therapeutic approach toward the specific patient needs in order to minimize the downgrading of potentially life-saving therapies.14 Until now, however, no precise evaluation of the impact that this strategy had in influencing the therapeutic approach and in improving patient outcome in our population has been performed. A retrospective evaluation of consecutive ACS patients, their clinical, biohumoral and procedural characteristics and the adopted pharmacological treatments is, therefore, an important epidemiologic tool for the characterization of this phenomenon and for identifying potential associations which could suggest possible future therapeutic developments.

NCT ID: NCT03583034 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Outcomes and Complications of Holmium Laser Enucleation of the Prostate in Expert Hands

ExpHo
Start date: June 18, 2018
Phase:
Study type: Observational [Patient Registry]

The efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) have been comprehensively assessed. However, HoLEP is considered as a challenging procedure with a steep learning curve. As such, HoLEP is not as yet considered the gold standard for the surgical treatment of LUTS/BPH by international clinical guidelines. The investigators aim to assess the complications and outcomes of patients treated with HoLEP by high volume surgeons, in order to provide data on the safety of the procedure and identify the profile of patients who may benefit from a dedicated clinical management to reduce the risk of post-operative complications.

NCT ID: NCT03582410 Completed - Clinical trials for Pelvic Organ Prolapse

Different Types of Suture for Sacral Colpopexy

Start date: July 10, 2018
Phase: N/A
Study type: Interventional

This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.