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NCT ID: NCT04372511 Completed - Pain Clinical Trials

Use of Binaural Beats for Colonoscopy

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Investigators verify the effectiveness of "binaural beats" to reduce pain during colonoscopy .

NCT ID: NCT04371809 Completed - Clinical trials for Coronary Artery Disease

DNA Methylation Analysis in Acute Coronary Syndrome and Atrial Fibrillation: DIANA Clinical Trial

Start date: March 20, 2019
Phase:
Study type: Observational

Although epigenetics has been identified as one of the most relevant pathophysiological components in the development of cardiovascular diseases, there is still considerable difficulty in finding markers of epigenetic damage useful in clinical practice. Moreover, these markers could be useful to predict the onset and severity of disease as well as to stratify stratification the prognostic risk during the follow-up. The aim of this project will be to evaluate the genome wide DNA methylation status in circulating CD4+ T cells and CD8+ T cells in patients with acute coronary syndromes (ACS), atrial fibrillation (AF) and with ACS in the presence of AF.

NCT ID: NCT04371562 Completed - COVID Clinical Trials

Predicting Death and ICU Admission in COVID-19 Patients in ED

Start date: March 1, 2020
Phase:
Study type: Observational

INTRODUCTION. The novel coronavirus designated SARS-CoV-2, has determined an international outbreak of respiratory illness named Covid-19. Patients with Covid-19 present primarily with fever, myalgia or fatigue, and dry cough. Based on available data from 5% to 10% among hospitalized patients will require ICU admission. In this context of overflow of critically ill patients, it is mandatory to establish clear and objective criteria to assess and predict a Covid-19 patient's need for ICU admission, and potentially predict death occurrence. Early Warning Scores (EWS) are used in hospitalized patients to predict clinical deterioration. Several study demonstrate the utility of EWS in ED to predict patient outcome. AIM. The objective of this study is to evaluate five EWSs, to predict the need for ICU admission and the mortality in patients admitted in ED with COVID-19. METHODS. This is a single-center, retrospective observational study. We will review the clinical records of all the patients consecutively admitted to our ED for Covid-19 over a three-weeks period (March 1 to 21, 2020). We will exclude from study cohort patients aged <18 years old and pregnant women, and patients already on oro-tracheal intubation at ED arrival. Based on clinical records five EWS will be calculated: NEWS, NEWS2, qSOFA, MEWS, REMS. Study endpoints. The primary study endpoints will be death at 7 days, and need for ICU at 7 days, since ED admission. As secondary endpoints we will evaluate need for ICU and death at 24 and 48 hours since ED admission. Statistical Analysis Receiver operating characteristic (ROC) curve analysis will be used to evaluate the overall performance of the selected EWSs in predicting the defined adverse outcomes. According to Youden's index we will estimate the optimal cut-off points and corresponding sensitivity and specificity at selected score threshold values. The comparison between the ROC AUCs will be made according to DeLong method.

NCT ID: NCT04371289 Completed - COVID-19 Clinical Trials

Predictors of Cardiovascular Risk in Covid-19 Patients During Acute Disease and at Short Term Follow-up

CARDICoVRISK
Start date: April 8, 2020
Phase:
Study type: Observational

Northern Italy, and particularly Lombardy, is one of the regions of the world mostly affected by COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To investigate the still largely unknown pathophysiology of this disease, we have built a consortium of Italian Hospitals to include a large cohort of COVID-19 patients from mild out-patients managed by GPs to inpatients developing mild, moderate or severe disease assessed both in hospital and at a 3-6 month follow-up visit). Consortium partners have a wide expertise to allow for 1) comprehensive assessment of risk factors for severe COVID-19 syndrome; 2) study the pathophysiology of its cardio-respiratory manifestations; 3) estimate risk scores also with artificial intelligence and 4) assess its clinical immunoinflammatory and cardiorespiratory sequelae in discharged patients at short term follow-up. To this aim, we will 1. Enroll around 5500 COVID-19 patients (1000 outpatients and 4500 in-patients), which will allow to: 1.1 Phenotype patients with COVID-19 of variable severity 1.2 Assess the prevalence of COVID-19 among GPs in relation with their use of PPE 1.3 Evaluate the impact of patients' demographic and clinical characteristics COVID-19 severity 2. Use an electronic CRF (on RedCap) to record clinical, biohumoral and imaging data of inpatients with COVID-19 of various severity to explore the prognostic and pathophysiological role of immunologic factors, activation of blood coagulation, endothelial dysfunction, inflammatory response, genetic (ni particular X-linked), hormonal and metabolic factors, comorbidities and acute cardiac damage. Blood samples will be collected. We will also use machine learning techniques to develop multivariable models for patients' risk stratification 3. A follow-up visit at 3-6 months after discharge will be performed to identify residual clinical consequences that might affect long-term prognosis.

NCT ID: NCT04368377 Completed - Respiratory Failure Clinical Trials

Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19

PIC-19
Start date: April 6, 2020
Phase: Phase 2
Study type: Interventional

This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).

NCT ID: NCT04367896 Completed - Clinical trials for COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION

COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION (SOT) : AN INTERNATIONAL WEB-BASED SURVEY

Start date: March 24, 2020
Phase:
Study type: Observational

Background COVID-19 has brought into questioning the equitable distribution of resources. Solid Organ Transplants (SOT) are life-saving procedures. Rapid changes in the management of patients are occurring, with potential for inequity. Drawing on professionals across transplant specialities, we investigated resource distribution specifically for SOT to guide healthcare policies. A multidisciplinary team developed a survey. The survey included demographic questions to contextualise respondents, questions on resource allocation for SOT. Multiple strategies were used to distribute the survey internationally. Descriptive, uni-multivariate ordinal regressions analysis were performed. Open comments were analysed using qualitative methods.

NCT ID: NCT04367571 Completed - Clinical trials for Spinal Cord Injuries

Osteopathic Manipulative Treatments and Neurogenic Bowel Dysfunction in Patients With Spinal Cord Injuries.

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Studies based on the relationship between Osteopathic Manipulative Treatment (OMT) and the gastrointestinal system have been conducted in patients with constipation with Irritable Bowel Syndrome (IBS), and in children with infantile cerebral palsy. For IBS patients, OMT can facilitate visceral vascularization and restore the physiological elasticity and motility of the viscera, and of the peritoneal structures around the viscera. The study also focused on the effects of OMT on women and constipated children, indicating an improvement in the stool consistency, reduction in the symptoms of constipation, the severity of the constipation, and in the use of laxative drugs. In patients with Spinal Cord Injury (SCI), the secondary health disorders include the alteration of gastric acid secretion, abnormal colonic myenteric activity, and neurogenic bowel dysfunction (NBD). Patients with NBD present loss or absence of normal bowel function. About 80% of SCI is accompanied by NBD resulting in a lower quality of life caused by loss of independence, sense of embarrassment, mental disorder, social isolation. Conservative treatments for NBD after SCI include oral laxatives, enemas, retroanal trans-grade irrigation and digital anorectal stimulation. These treatments are mainly focused on promoting intestinal faecal evacuation and on strengthening the anal sphincter to improve bowel function. There are no studies that investigate the effects of OMT on patients with SCI, however, several studies have already showed the effects of OMT on the nervous system, on the hemodynamic system, and on visceral motility. Therefore, the starting hypothesis of this study is to use OMT in order to improve the symptoms of NBD in subjects with SCI, through a global OMT

NCT ID: NCT04367454 Completed - Cardiac Arrest Clinical Trials

Procedures While Wearing CBRNe Protective Equipment

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Out-of-hospital care during Chemical-Biological-Radiological-Nuclear-explosive (CBRNe) events have recently evolved, but the available knowledge is still extremely partial. In particular, the debate is still ongoing regarding which life-saving maneuvers should be implemented in the pre-decontamination phase while wearing CBRNe personal protective equipment (PPE). The investigators hypothesized that PPE may lengthen the execution times and worsen the success rate of invasive and non-invasive procedures. This trial involves residents in emergency medicine and anesthesia/critical care of the University of Padova (Italy) with the following procedures performed on high-fidelity manikins, after being divided into two groups (wearing and not wearing PPE): positioning of peripheral venous access; intraosseous access; drug preparation and administration; tension pneumothorax (PNX) needle decompression; tourniquet positioning; chest compressions. The primary outcome was the chest compressions depth mean difference between the two groups. As secondary outcomes, the investigators measured differences between the two groups in: the percentages of correct release during chest compressions; chest compressions rate (beats per minute); and the times needed to complete the above-mentioned procedures (other than chest compressions). The investigators expect that PPE will reduce CPR quality or delay the completion of the procedures.

NCT ID: NCT04367337 Completed - Health Behavior Clinical Trials

Health Behavior Change During COVID-19 Pandemic

Start date: March 25, 2020
Phase:
Study type: Observational

This study aims at investigating handwashing behavior during COVID-19 pandemic. It was hypothesized that social-cognitive and emotional predictors as well as COVID-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.

NCT ID: NCT04367285 Completed - Multiple Sclerosis Clinical Trials

Sensor-based Technology for Upper Limb Rehabilitation

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper extremities function limitations. The sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database in order to quantitatively monitoring measures and therapy progress. The aim of this study is to evaluate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limbs functions of MS patients. The training consisting of twelve sessions of upper limb training, was compared with twelve sessions of upper limb sensory-motor training, without robotic support. Both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to the conventional therapy. All patients were evaluated at baseline (T0) and after 4 weeks of training (T1)