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NCT ID: NCT04366921 Recruiting - Septic Shock Clinical Trials

European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO

EuroECMO-COVID
Start date: April 10, 2020
Phase:
Study type: Observational

In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally. In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively. Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%. The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality. Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project. The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

NCT ID: NCT04365972 Completed - Anxiety Clinical Trials

Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic

Start date: April 23, 2020
Phase: N/A
Study type: Interventional

The outbreak of the 2019 Coronavirus (COVID-19) pandemic is a major stressor leading to increased levels of anxiety, and specifically, an excessive fear of being infected and affected by the disease among major parts of the population. At the same time, the access to mental health services is limited due to the lockdown policy applied in many countries worldwide, warranting the development of home-delivered interventions aimed at reducing stress and anxiety symptoms. Attention Bias modification (ABM) has been found to be an efficacious computerized intervention to reduce anxiety symptoms. In this open pilot trial, participants reporting on elevated levels of health anxiety concerning the COVID-19 epidemic will receive one session of ABM over 5 consecutive days (5 sessions total). Symptoms of health anxiety, state anxiety, generalized anxiety, and depression will be measured at baseline and post-treatment.

NCT ID: NCT04365868 Active, not recruiting - Cirrhosis Clinical Trials

Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

NAVIGATE
Start date: June 22, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

NCT ID: NCT04365400 Terminated - Type 2 Diabetes Clinical Trials

Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes

TRIAGE
Start date: October 13, 2020
Phase: Phase 2
Study type: Interventional

To assess the efficacy and safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes

NCT ID: NCT04364269 Completed - Beta-Thalassemia Clinical Trials

Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia

VITHAL
Start date: June 11, 2020
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo-controlled parallel group trial to investigate the safety, tolerability and efficacy of multiple doses of VIT-2763 versus placebo in participants with non-transfusion-dependent Beta-thalassemia (NTDT).

NCT ID: NCT04363281 Completed - Pain Clinical Trials

The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception

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

In this study we will assess the incidence and severity of intraoperative and postoperative pain and determine the effect of preoperative anxiety on intraoperative and postoperative pain incidence. Secondary outcome is to assess provider perception of pain.

NCT ID: NCT04363073 Completed - Breast Feeding Clinical Trials

Assessment of Annabella Breast Pump Performance

Start date: December 30, 2020
Phase: N/A
Study type: Interventional

This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.

NCT ID: NCT04360746 Completed - Hip Fractures Clinical Trials

The Influence of Clinical Pharmacist on the Quality of Drug Prescribing and Rehabilitation Outcomes in Post-acute Hip Fractured Patients

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

The influence of clinical pharmacist on various drug related outcomes was reported in different healthcare setting including the community, long term care and during acute hospitalization. Nevertheless, data on the influence of clinical pharmacist intervention on the quality of drug prescribing and rehabilitation outcomes in post-acute hip fractured patients is scarce. The aims of the current study are to evaluate the contribution of a clinical pharmacist on the appropriateness of drug prescribing among post-acute geriatric hip fractured patients and to investigate whether this involvement can improve rehabilitation outcomes. The investigators hypothesis is that early review of geriatric hip fractured patients medical record by a clinical pharmacist will improve the appropriateness of drug treatment and the rehabilitation outcomes among this population.

NCT ID: NCT04359979 Recruiting - Thyroid Eye Disease Clinical Trials

Tamsulosin for Thyroid Lid Retraction

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

The purpose of this study is to examine the effect of using Tamsulosin for treatment of eyelid retraction as part of thyroid eye disease. The treatment will be offered to all thyroid patients suffering from eyelid retraction who are treated at the thyroid clinic in Sheba's Ophthalmology department. All patient will receive information about the drug Tamsulosin, the possible side effects, and the alternative treatment options for retraction. Patients recruited will take 0.4mg/day Tamsulosin for 3 months and will have follow-ups at 1 week, 1 month and 3 months to evaluate the retraction status.

NCT ID: NCT04358926 Completed - COVID-19 Clinical Trials

Hyperbaric Oxygen Therapy Effect in COVID-19 RCT (HBOTCOVID19)

HBOTCOVID19
Start date: April 30, 2020
Phase: N/A
Study type: Interventional

The 2019-20 coronavirus disease, caused by COVID-19, is an ongoing pandemic.So far, no specific treatment has proven efficacy. Recent case series reported the use of Hyperbaric Oxygen Therapy (HBOT) on 5 severe COVID-19 patients who developed respiratory insufficiency. HBOT mechanisms of tissue oxygenation and anti-inflammatory effect may explain these findings. The purpose of the current study is the evaluate the efficacy of HBOT in moderate-severe COVID-19 patients in a randomized controlled manner.