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NCT ID: NCT05229263 Recruiting - Healthy Clinical Trials

Multiparametric MRI in Healthy Volunteers and CKD Patients

RESPECT
Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population. The majority of the people with CKD aren't aware and there are not available tools for early CKD detection and for an accurate prediction on these patients. Many CKD patients exhibit progressive renal dysfunction, demonstrating a failure of current, non-specific therapeutic strategies. Better methods are urgently needed for i) early diagnosis of CKD, and prediction of its progression for improved stratification of patients and better targeting of current treatments; and ii) to directly assess structural and functional responses of the kidney to new therapies and identify those patients who respond. Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising technique for improved understanding and characterisation of renal pathophysiology. Compared to histopathology, MRI is non-invasive and avoids sampling bias by characterising the entire kidney with high spatial resolution. In spite of a number of single centre studies showing renal MRI feasibility and potential to address a number of key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Standardization of acquisition and processing protocols across centres is therefore needed, and this will also lead to the possibility to provide preliminary data of the multiparametric renal MRI clinical validity and utility. The purpose of this study is to standardize, assess the feasibility and provide preliminary evidence of clinical validity and utility of the multiparametric renal MRI. To reach this goal two groups of subjects are involved: - Group 1 (healthy volunteers). In this group the repeatibility and reproducibility of multiparametric renal MRI will be assessed. - Group 2 (CKD patients). In this group the feasibility, the acceptability, the reproducibility and the preliminary clinical validity of multiparametric renal MRI will be assessed.

NCT ID: NCT05229198 Recruiting - Clinical trials for Astrocytoma, Grade IV

ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas

ALBATROSS
Start date: June 1, 2020
Phase:
Study type: Observational

This Clinical study is framed in the ALBATROSS Project: Clinically validated decision support system based on pixel level Artificial Intelligent models for deciding treatment in glioblastoma. The prospective multicenter international dataset compiled during the ALBATROSS project will include a cohort up to 300 new patients diagnosed with GB after June 1, 2020. Longitudinal images (T1, T2, T1c, FLAIR, PWI-DSC and DWI at least), complete molecular profiling, primary and secondary lines of treatment and clinical conditions will be included for each patient.

NCT ID: NCT05228691 Recruiting - COVID-19 Clinical Trials

Prevalence of Long COVID-19 in the Canary Islands

Start date: March 22, 2022
Phase:
Study type: Observational [Patient Registry]

With more than 246 million people diagnosed with coronavirus 2019 (COVID-19) around the world, many of whom have required medical attention for past 23 months, greater emphasis is being placed on post-acute care of COVID-19 survivors. According to recent data, millions of patients who have recovered from acute COVID-19 are experiencing persistent symptoms, which lead to disability and impaired activities of daily living. Various terms have been used to describe the condition of patients who do not return to their initial health status to include post-acute sequelae of COVID-19, such as post-acute COVID syndrome (PACS) and Long COVID. The growing global burden of COVID-19 suggests that the potential effects of Long COVID in public health are vast even if Long COVID is experienced by a small proportion of patients recovering from acute infection. The ability to identify patients at high risk for Long COVID and forecasting medical resource requirements is of important clinical utility in the present. In view of the large number of people surviving after infection with COVID-19 and that should require follow-up, determine which patients are at risk of have Long COVID and who require close monitoring is crucial. In this study, therefore, we set out to analyze what type of patient profile with COVID-19 who, after 12 weeks of having suffered the infection, experiences the signs and symptoms described by current literature.

NCT ID: NCT05225961 Recruiting - Clinical trials for Acute Ischemic Stroke

ATILA Project: Aspirin Versus Tirofiban in Endovascular Treatment for Patients With Acute Ischemic Stroke Due to Tandem Lesion

ATILA
Start date: May 1, 2022
Phase: Phase 4
Study type: Interventional

Patients with tandem lesions (TL) are defined as patients with an acute ischemic stroke (AIS) with occlusion of an intracranial vessel of the anterior circulation and an occlusion or severe stenosis (70-99%) of the origin of the ipsilateral internal carotid artery (ICA). The greatest current limitation in the management of this type of lesion is the use of antithrombotic medication (double antiaggregation) in the acute phase that is required in case of placing extracranial stent to stabilize the atheroma plaque. In relation to this antiplatelet regimen, the latest clinical practice guidelines warn about the risk of combining intravenous fibrinolysis with antiplatelet medication in the acute phase, since it seems to increase the risk of symptomatic intracranial hemorrhage (sICH). However, the non-stabilization of the carotid atheroma plaque is associated with higher rates of cervical reocclusion, poorer functional prognosis, and higher mortality. Therefore, the use of a single antiplatelet agent could be a reasonable alternative. To establish the best protocol for mono-antiaggregant therapy in the acute phase of TL, the investigators propose to carry out a prospective multicenter randomized clinical trial. 1. All patients with ischemic stroke secondary to TL in the anterior circulation candidates for mechanical thrombectomy in whom cervical endoprosthesis will be placed in the acute phase, will be included, randomized to two groups: 500 mg of intravenous (iv) Aspirin vs Low dose regimen of Tirofiban iv. 2. Carotid reocclusion rates and sICH rates will be evaluated within the first 24 hours after mechanical thrombectomy . As a secondary objective, the functional prognosis at 3 months in both groups will be analyzed, as well as a panel of biomarkers predictors of reocclusion in both groups. Establishing an antiplatelet management protocol in the acute phase in these patients would be an innovative strategy not developed by any other group worldwide, and would place us at the forefront of research in the field. Likewise, developing a clinical-biological predictive model of carotid reocclusion will allow us to establish risk patients in which to plan alternative treatments. Reference hospitals in the treatment of ischemic stroke at the national level with sufficient experience in the management of this pathology will participate in the project.

NCT ID: NCT05225714 Recruiting - Laceration Clinical Trials

Dermal Wound Closure Using Silkam®

DERMASILK
Start date: July 21, 2022
Phase:
Study type: Observational

Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.

NCT ID: NCT05225636 Recruiting - Clinical trials for Ischemic Stroke, Acute

Stroke Process in FEmoral Versus Radial Access

SFERA
Start date: September 15, 2021
Phase: N/A
Study type: Interventional

In patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process.

NCT ID: NCT05223413 Recruiting - Lymphoma Clinical Trials

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

RESILIENCE
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in Lymphoma patients receiving anthracyclines.

NCT ID: NCT05222958 Recruiting - Pregnant Women Clinical Trials

Effectiveness of an App for Tobacco Cessation in Pregnant Women (TOBBGEST)

TOBBGEST
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Background: Tobacco use during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant women and their fetus. Despite the fact that smoking among pregnant has decreased in recent years, smoking continues to be a major public health problem. Hypothesis / Research question: The use of new technologies such as applications (apps) for mobile devices designed with a gamification strategy (understood as an incentive through play) could help women to quit smoking during pregnancy and in the long term. A structured App-based intervention using gamification adapted to pregnant women will decrease smoking prevalence in this population. Objectives: To evaluate the effectiveness of an intervention against tobacco in pregnant women based on an app for tobacco abstinence. Specific objectives: 1) To determine the effectiveness of the intervention on smoking cessation during pregnancy, 2) Determine the effectiveness of the intervention in in the long term and 3) To determine the impact of the intervention to reduce smoking in pregnant women who continue smoking. Design: Randomized, multicentre community intervention trial Setting: Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Centres. Intervention: the participants will have the usual clinical practice intervention and the intervention group (IG) will also have access to an app based on gamification, verified by coximetry during the follow-up, and with a cotinine test at the end. Analysis: of groups "by intention to treat", abstinence rates will be compared and the determining factors will be evaluated using multivariate statistics. Expected results: smoking cessation in the IG will be > 5%, compared to normal practice. Applicability and Relevance: It promotes activities aimed to reduce tobacco consumption in the general population, and especially in women, in order to decrease comorbidity associated with long-term smoking, which will lead to a reduction in tobacco-related diseases in the whole population.

NCT ID: NCT05222529 Recruiting - Asthma Clinical Trials

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma

Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.

NCT ID: NCT05222139 Recruiting - Clinical trials for SARS CoV 2 Infection

Monitoring COVID-19 Vaccination Response in Fragile Populations

ORCHESTRA-4
Start date: May 24, 2021
Phase:
Study type: Observational

The present study is part of ORCHESTRA project, a three-year international research project aimed at tackling the coronavirus pandemic. ORCHESTRA provides an innovative approach to learn from the pandemic SARS-CoV-2 crisis, derive recommendations to further management of COVID-19 and be prepared for the possible future pandemic waves. The ORCHESTRA project aims to deliver sound scientific evidence for the prevention and treatment of the infections caused by SARS-CoV-2 assessing epidemiological, clinical, microbiological, and genotypic aspects of population, environment and socio-economic features. The project builds upon existing, and new largescale population cohorts in Europe (France, Germany, Spain, Italy, Belgium, Romania, Netherlands, Luxemburg, and Slovakia) and non-European countries (India, Perú, Ecuador, Colombia, Venezuela, Argentina, Brazil and Gabon) including SARS-CoV-2 infected and non-infected individuals of all ages and conditions. The primary aim of ORCHESTRA is the creation of a new pan European cohort applying homogenous protocols for data collection, data sharing, sampling, and follow-up, which can rapidly advance the knowledge on the control and management of the COVID-19. ORCHESTRA will include SARS-CoV-2-negative individuals and thereby enable a prospective follow-up and an analysis of vaccination response. The cohort will involve four different populations: general population, COVID-19 patients, fragile individuals (children, elderly, transplanted, oncological, HIV infected, and those with Parkinson disease), and health-care workers. Each of these "perpetual" cohorts can answer different research questions and vaccine strategies. Within the ORCHESTRA project, the Work Package 4 (WP4) will focus on the cohort of fragile patients including pregnant women/new-born, children, patients with HIV infection, patients with autoimmune disease, solid organ transplant recipients, patients with oncological and hematological diseases, patients with cystic fibrosis, patients with Parkinson Disease and rheumatological diseases from from 14 countries (5 European and 9 non-European countries), with approximately 20000 subjects.