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NCT ID: NCT04392557 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Anti-inflammatory Status in DM2 Treated Patients

INF-DM2-Ther
Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

Diabetes mellitus Type 2 (DMT2) - a progressive insulin secretory defect on the background of insulin resistance - is one of the major risk factors for atherosclerosis, an inflammatory disease of the arterial wall, in which leukocytes and oxidized lipoproteins accumulate leading to formation of fatty streaks and atherosclerotic plaques. Atherosclerosis accounts for more than 600,000 deaths annually in the U.S. mainly due to acute myocardial infarction and stroke. Pharmacological therapy of DMT2 includes several drugs used as monotherapy, although combination therapy between metfomin plus thiazolidinediones (TZD) and/or dipeptidyl-peptidase 4 inhibitors (DPP4I) plus TDZ, may delay atherosclerosis progression even if the molecular mechanisms are not clear. Even if normoglycemia is achieved, DMT2 patients still displayed a higher risk for developing atherosclerosis suggesting that other mechanisms of the inflammatory status are involved

NCT ID: NCT04389372 Recruiting - Migraine Headache Clinical Trials

Effectiveness and Acceptability of MINDFULNESS by Smartphone, for Patients With Chronic Migraine and Medication Overuse

ChroMig-Smart
Start date: March 15, 2020
Phase: N/A
Study type: Interventional

Chronic Migraine is a disabling condition that affects the 2% of migraine population. It is often associated with medication overuse that makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse but it is also confirmed that patients have to be carefully followed in the last period after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. It has been also reported how the clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. Generally patients after withdrawal follow a specific prophylaxis for migraine, but also come weekly to the hospital for practicing mindfulness for 6 sessionsAs the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients will miss the possibility to come for the regular practice to the hospital: for this reason the investigator propose a small pilot study to enforce the use of technology for our patients so that they can continue to be followed in their therapeutic process. This preliminary study will be conducted on 25 patients that have been submitted to a withdrawal according to the standard procedure at our hospital and they will practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital and also a weekly video-call to evaluate the clinical condition and to encourage to use strategies for pain management. This modality will allow the patients to continue their therapeutic process and to be followed regularly during the one year after withdrawal

NCT ID: NCT04388670 Recruiting - COVID-19 Clinical Trials

Epidemiological and Clinical Characteristics of Critically Ill Patients With COVID-19

2019nCoV_ICU
Start date: February 22, 2020
Phase:
Study type: Observational

Objective of this observational multicentric retrospective-prospective study is to describe the number and the characteristics of patients with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV2 positivity admitted to Intensive Care Units during the first 6 months of epidemic.

NCT ID: NCT04388514 Recruiting - Clinical trials for SARS-CoV-2 Respiratory Failure

Blood Ozonization in Patients With SARS-CoV-2 Respiratory Failure

CORMOR
Start date: April 8, 2020
Phase: N/A
Study type: Interventional

Aim. The emerging outbreak of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Beside the prescription of some promising drugs as chloroquine, azithromycin, antivirals (lopinavir/ritonavir, darunavir/cobicistat) and immunomodulating agents (steroids, tocilizumab), in our patients with mild to moderate pneumonia due to SARS-CoV-2 we planned a randomize study to evaluate, respect the best available therapy (BAT), the use of autohemotherapy treatement with an oxygen/ozone (O3) gaseous mixture as adjuvant therapy. Design. Multicentric, randomized study. Participants. Clinical presentations are based upon clinical phenotypes identified by the Italian Society of Emergency and Urgency Medicine (SIMEU - Società Italiana di Medicina di Emergenza-Urgenza) and patients that meet criteria of phenotypes 2 to 4 were treat with best available therapy (BAT), and randomized to receive or not O3-autohemotherapy. Main outcome measures. The end-point were the time of respiratory improvement and earlier weaning from oxygen support: these parameters were included in the SIMEU clinical phenotypes classification.

NCT ID: NCT04387929 Recruiting - COVID-19 Clinical Trials

Detection of Anti-COVID-19 Antibody Levels in an Hospital Population

Start date: May 4, 2020
Phase:
Study type: Observational [Patient Registry]

COVID-19 (SARS-CoV-2) infection in health professionals represent a significant criticality both for the risk of spreading the disease and for the organizational aspects that follow. The objective of the study is to evaluate the spread of COVID-19 virus within the hospital population of Humanitas through the monitoring of the levels of IgG antibodies. Moreover, viral load will be measured by RT-PCR in the subgroup positive to IgG antibodies.

NCT ID: NCT04385160 Recruiting - COVID Clinical Trials

Myeloproliferative Neoplasms (MPN) and COVID-19

MPN-COVID
Start date: May 13, 2020
Phase:
Study type: Observational

An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.

NCT ID: NCT04385043 Recruiting - COVID-19 Clinical Trials

Hyperimmune Plasma in Patients With COVID-19 Severe Infection

COV2-CP
Start date: May 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Passive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma - or "hyperimmune" plasma was one of the most widespread and effective anti-infective treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions. To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent responsible for the disease called Covid-19. Among those subjected to clinical studies during the current epidemic in China, hyperimmune plasma appears to be one of the most rational and promising. The objective of this study will be to evaluate the efficacy and safety of the hyperimmune plasma administered add-on to the anti-Covid-19 treatment (standard therapy) according to clinical practice in patients with severe Covid-19 infection, compared to patients with severe Covid-19 infection treated only with standard therapy.

NCT ID: NCT04384484 Recruiting - Clinical trials for Refractory Diffuse Large B-Cell Lymphoma

Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

LOTIS 5
Start date: September 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.

NCT ID: NCT04383834 Recruiting - Clinical trials for to Study Soft Tissue Health and Stability

A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________

Start date: April 1, 2019
Phase:
Study type: Observational [Patient Registry]

Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes

NCT ID: NCT04383119 Recruiting - Soft Tissue Sarcoma Clinical Trials

Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

ISG-ARTICLE
Start date: October 29, 2021
Phase: Phase 2
Study type: Interventional

Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.