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NCT ID: NCT04707235 Recruiting - Sickle Cell Disease Clinical Trials

ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study

Start date: August 21, 2020
Phase:
Study type: Observational

As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.

NCT ID: NCT04702880 Recruiting - Clinical trials for Extensive-stage Small Cell Lung Cancer

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).

NCT ID: NCT04701983 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

AERIFY-1
Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

NCT ID: NCT04697251 Recruiting - Respiratory Disease Clinical Trials

Infant Forced Oscillations Technique (iFOT)

iFOT
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The aim of this study is the implementation of Forced Oscillations Technique (FOT) in newborns and small infants using a novel commercially available device. The objective is to assess the feasibility of the method, provide normative data for the first months of life and describe short- and long-term changes in neonatal respiratory disorders. The study population will consist of term and preterm newborns admitted to the Neonatal Intensive Care Unit (NICU) or the Well-Baby Nursery of the University Hospital of Patras, Greece. It is estimated that 200 full-term and 150 preterm newborns will be enrolled during a period of 36 months (March 2021 - September 2022). Measurements will be performed using the TremoFlo N-100 via a face mask, with the infant in the supine position during natural sleep. At least 3 technically acceptable measurements (duration 10s each) will be obtained, as follows: - Healthy full-term neonates: postnatal days 1, 2, 3 and at discharge - Preterm neonates: NICU admission, postnatal days 1, 2 and 3, and on the first day of each additional gestational week until discharge All participants will be also measured at the age of 3, 6 and 12 months.

NCT ID: NCT04696276 Recruiting - Ovarian Cancer Clinical Trials

Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece

ERAS
Start date: January 6, 2020
Phase: N/A
Study type: Interventional

The Enhanced Recovery After Surgery (ERAS) program includes preoperative counseling, fasting avoidance, non-opioid analgesia, fluid balance, normothermia and early mobilization. ERAS pathways were developed to reduce hospital length of stay, reduce costs and decrease perioperative opioid requirements, and be beneficial for patients. We propose the hypothesis that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients undergoing major gynecolodic oncology surgery (MGOS). Patients were randomly allocated in two groups: An ERAS pathway group including preoperative counseling, early feeding/mobilization, and opioid-sparing multimodal analgesia; and a classic model group of post operative recovery as control.

NCT ID: NCT04695587 Recruiting - Clinical trials for Takotsubo Cardiomyopathy

The Role of Sympathetic Tone Regarding the Anatomical and Functional Recovery of the Left Ventricle in TakoTsubo Syndrome

SYMPATAK
Start date: October 8, 2019
Phase:
Study type: Observational

TakoTsubo Syndrome (TTS) constitutes an increasingly recognised, heterogenous clinical entity which is associated with considerable short-term mortality. In addition, emerging evidence suggests that, in the long term, TTS can induce the expression of a phenotype similar to HFpEF . Apart from the typical (apical left ventricular) type, the current TTS definition has been expanded to also include the mid-ventricular, the basal and the focal type. Several previous studies on the typical form of the syndrome demonstrated that the principal underlying pathophysiology is sympathetic overactivation. Purpose The aim of this study is to investigate the potential association between the sympathetic tone and the acute phase clinical features of TTS. Furthermore, the investigators aim at exploring possible correlations between the sympathetic tone activity and the diastolic dysfunction, a reported complication occurring one year after the acute phase. This is a prospective observational study enrolling patients aged 18-85 years who fulfill the InterTaK diagnostic criteria and whose CMR within 14 days of the onset is not suggestive of an alternative diagnosis. All patients will be treated on individual basis according to the recent expert consensus statement for TTS. During the baseline evaluation the sympathetic tone will be assessed by means of Muscle Sympathetic Nerve Activity study (MSNA), heart rate and blood pressure variability parameters. Additionally, in a subgroup of participants sympathetic activity and cardiac sympathetic enervation will be evaluated with radioactive Iodine Metaiodobenzylguanidine scintigraphy (mIBG). Sequential echocardiography and CMR indices will be used for heart function and geometry assessment. The investigators will investigate the correlation between the sympathetic tone and the severity of cardiac dysfunction (systolic and diastolic) during the acute phase. Furthermore, the investigators will examine differences of the sympathetic tone effect in association with the localisation of the wall motion abnormality. Stress levels and quality of life will be assessed with respective validated questionnaires. The participants will be followed-up with quarterly clinic reviews for 12 months after the acute event. Baseline measurements will be repeated at the end of the follow-up period. Ethics approval has been obtained from the hospital ethical committee board. The study results are expected to determine the role of the sympathetic tone on the extend, the severity and the localisation of cardiac dysfunction during the acute phase. They are also expected to demonstrate the role of the sympathetic tone on the long-lasting disorder that persists for months following the acute event.

NCT ID: NCT04693936 Recruiting - Psoriasis Clinical Trials

Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

Start date: February 2, 2021
Phase: N/A
Study type: Interventional

Hashimoto's disease (HT) and psoriasis (PsO) have a significant impact on patient's quality of everyday life, and early diagnosis is critical for the symptoms management and prognosis. There is evidence that HT and PsO share common metabolic pathways that relate to their pathogenesis, and are affected by dietary and lifestyle factors. Previous studies have identified potential metabolic biomarkers, although the small number of studies hamper their validation. Of note, most studies are not longitudinal thus do not capture the metabolic fluctuations in response to disease progression or dietary changes. Thus, the purpose of this study is to identify metabolic biomarkers of HT and PsO and study the role of epigenetic factors (diet and lifestyle) on the involved metabolic pathways . In addition, a comparative analysis of the disease-related quality of life (QoL) will be performed in relation to dietary changes to unravel possible links between the QoL and the associated metabolic pathways in HT and PsO.

NCT ID: NCT04681612 Recruiting - Clinical trials for Myocardial Infarction With Nonobstructive Coronary Arteries

The Prognostic Role of Indices of Sympathetic Nervous System Overdrive in MINOCA

PRISMA
Start date: October 8, 2019
Phase:
Study type: Observational [Patient Registry]

Myocardial infarction with non-obstructive coronary arteries (MINOCA) occurs in 1-13% of all patients with acute myocardial infarction (AMI). According to most studies MINOCA patients seem to have a more favorable prognosis compared to the obstructive AMI ones, but face a significant risk for recurrent events of angina. It has been demonstrated that sympathetic nervous system (SNS) overdrive during the acute phase of an acute coronary syndrome (ACS) has a deleterious impact on cardiovascular morbidity and mortality and this is the reason why contemporary treatment strategy of ACS aims towards the inhibition of SNS mechanisms. In the setting of MINOCA, however, data are scarce regarding the prognostic role of SNS activation and the concomitant utility of a similar therapeutical approach. The aim of this study is to investigate the potential role of SNS in cardiovascular prognosis of MINOCA patients. In the same context, this study is the first, to the investigators' knowledge, registry where the working diagnosis of MINOCA will be confirmed with cardiac magnetic resonance (CMR) imaging. This is an observational cohort study with a prospective follow-up of 18 months enrolling all patients aged 38-85 years old who fulfill the diagnostic criteria of MINOCA. Patients will receive treatment according to the latest guidelines and consensus documents. Assessment of SNS will include calculation of indices of heart rate and blood pressure variability, as well as the measurement of muscle sympathetic nerve activity (MSNA) during the first 14 days following the event. Follow-up will include a phone contact at 3, 6 and 12 months to record potential primary endpoints and a clinic visit at 18 months to reassess clinical and lab parameters and record primary and secondary endpoints. Definition of primary endpoints includes hospitalization for new onset of ACS, heart failure, stroke or transient ischemic attack, cardiovascular death or death from any cause. Secondary endpoints include the burden of arrythmias estimated from 24hr ECG recording, recurrent angina assessed via Seattle Angina Questionnaire (SAQ) and the general health condition and quality of life (QoL) assessed using SF-12 questionnaire. The results of this study are expected to reveal the prognostic role of SNS assessment in patients with MINOCA with a potential clinical implication in a treatment approach towards the inhibition of SNS mechanisms.

NCT ID: NCT04681131 Recruiting - Clinical trials for Non-Small-Cell Lung Cancer

CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC

Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC

NCT ID: NCT04680299 Recruiting - Emergencies Clinical Trials

European Geriatric Emergency Departments Registry Study

EGERS
Start date: October 15, 2020
Phase:
Study type: Observational [Patient Registry]

Geriatric presentations to emergency services comprise a significant percentage of all emergency service presentations in Europe and it has been reported that 3-23% of all emergency service presentations from various regions of the countries. There are specific management practices for patients who are 65 years and older at emergency services. On the other hand several risk-scoring systems have been developed to define the severity class of the patient during their initial evaluation at emergency services.Only a few studies in the literature have evaluated risk-scoring systems for the geriatric patient group.Several studies have reported that risk-scoring systems, such as Identification of Seniors at Risk and Triage Risk Screening Tool, which are specifically developed for geriatric patients over 65 years who present to emergency services, are not sufficiently effective for evaluating patients in more severe conditions. Previously the TEDGeS (Turkish Emergency Departments Geriatric Scoring Study) pilot study was carried out and published by some of the investigators of this project.This pilot study enrolled all geriatric patients (age ≥ 65 years) and carried out in 13 centers from different cities of Turkey. This pilot study showed that geriatric patients not only constitute significant proportion of emergency department presentations but also these patients need more hospitalization. The predictive powers of the Modified Early Warning Score, Rapid Emergency Medicine Score and The Vital PAC Early Warning Score for hospitalization and mortality in geriatric patients those presented to emergency department are significantly high and might be concerned in the emergency department triage of these patients. Within the light of these pilot study results, the investigators have decided to execute this prospective, multinational, multicentric study with the main objective to determine the epidemiological and age related characteristics of geriatric patients presenting to the emergency department across Europe and evaluate early warning scoring systems systems regarding hospitalization, ICU admission and in-hospital mortality for geriatric patients.