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NCT ID: NCT04106037 Completed - Clinical trials for Legionnaires' Disease

Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.

Start date: August 13, 2019
Phase:
Study type: Observational

Legionnaire's disease (LD) is a major cause of both community acquired and nosocomial pneumonia, with Legionella pneumophila serogroup A (Lp1) being the most virulent and the greatest cause of disease. Sample culture of low respiratory tract is considered the gold standard in the diagnosis of LD, however its sensitivity seems to be poor and its performance is technically demanding. The introduction of urinary antigen detection testing (LUA) brought a major advance in LD diagnosis, with upt to 95% of cases in Europe being diagnosed with this method. Despite the high sensitivity of LUA for Lp1, ranging from 80-90%, its negative predictive value is low in other serogroup than Lp1 and therefore, Legionella may be unrecognized as agent of pneumonia. Although underdiagnosed and underreported, LD represents the second most common cause of pneumonia requiring admission in intensive care unit (ICU). Average fatality rate of LD in Europe reaches 10%, but its mortality is considered to be even higher in nosocomial patients. Despite the higher fatality rate in hospitalized LD patients, poor is the knowledge on the risk factors that could induce disease and that increase mortality in the hospitalized population affected by LD. In order to shed more light on this topic a cohort of patients diagnosed with LD in the last 3 years will be retrospectively examined.

NCT ID: NCT04105972 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del

Start date: October 3, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for F508del.

NCT ID: NCT04103632 Completed - Adolescent Clinical Trials

Screening and Diagnosing Exercise-induced Bronchoconstriction in Recreational Young Athletes (12-18 y)

Start date: October 23, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to validate the screening protocol to study risk factors of exercise-induced bronchoconstriction (EIB) obtained in our previous study in high-school elite athletes (NCT03587675), in recreational young athletes who perform intense physical exercise.

NCT ID: NCT04103203 Completed - Sepsis Clinical Trials

Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

FAPIC-QE
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The performance and clinical impact of two diagnostic systems will be evaluated using whole blood samples that are collected in parallel with samples for blood culture. As the rapid diagnostic systems will have the largest impact on severely ill patients (in need of a fast diagnosis) with bacterial infection, the evaluation will be performed in patients suspected of bacteraemia. During the study the new systems will be used in parallel with routine blood cultures. In alternating periods of 1 month, the results of the diagnostic system will be communicated to treating physicians (intervention) or not revealed (control). Blood culture results will be reported throughout the complete study period. Patients with suspected sepsis at the Emergency Department (ED), the department of infectious diseases/nephrology, and the department of haemodialysis will be included. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood sample (EDTA tube, 9 ml of blood) will be sampled for each routine set of blood cultures. In addition, the clinical data of the patients will be collected. The samples will be sent to the clinical laboratory where samples are tested with the new systems during regular working hours in batches of 8 samples per run (2-3 runs per day). On average, 10%-20% of the blood cultures drawn on the presumption of bacteraemia yield bacterial pathogens. Previous data show that 13% of patients yield positive blood cultures. Thus, in order to collect blood samples of 100 new episodes of bacteraemia approximately 1000 patients (2000 blood cultures + 1000 EDTA tubes) have to be collected for each system (2000 patients in total). The results of the systems will be used to evaluate the clinical utility of the system regarding time to antibiotic treatment change and bacteraemia management. The system will be used directly for the diagnosis of patients, resulting in a possible change of treatment strategy. However, routine blood culture practices will still be done during the whole study period.

NCT ID: NCT04102189 Completed - Obesity Clinical Trials

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Start date: October 7, 2019
Phase: Phase 3
Study type: Interventional

This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.

NCT ID: NCT04098926 Completed - Breast Cancer Clinical Trials

Highly Accelerated Dose-Integrated Radiotherapy in 5 Fractions in Breast Cancer

HAI-5
Start date: January 2015
Phase: N/A
Study type: Interventional

Adjuvant radiotherapy in breast cancer improves local control, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy. Improved local control leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011). Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often omitted. Following reasons are invoked: - frailty of the patient - fear for toxicity - impaired mobility, rendering transportation and positioning more difficult - dependency for transportation to and from the radiotherapy departement - negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy) Hypofractionation is feasible without increased toxicity, and combines better local control with patient comfort and lower costs. Further lowering the number of fractions (from 15-21 to 5) will further improve patient comfort, but is challenging when different doses are needed in the same target volume. This problem is addressed using advanced techniques permitting dose-integration. In the elder with cancer, several unrecognized geriatric problems, including depression and cognitive impairment, can be detected by CGA . Some problems do interact with cancer treatment. In this study screening and assessment is provided to support patients and to develop an inventory of radiotherapy obstacles. Our study includes breast cancer patients, ≥70 years old, referred for adjuvant radiotherapy after surgical treatment. A schedule of 5 fractions is offered, encompassing different targets of treatment.

NCT ID: NCT04098523 Completed - Clinical trials for Abdominal Aortic Aneurysm

Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.

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

Both abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS) are frequent clinical entities, with major morbidity and mortality. This project obtains robust data on the prevalence of AAA and CAS in the Brussels Capital Region. Using duplex ultrasound, a low invasive examination, we want to obtain information on a vast sample of men and women of the Brussels capital region, starting at the age of 60. With these data we can have a far better view on the Belgian situation of these two main vascular clinical entities. The data can provide insights on if, and how, Belgian public health policy can be improved concerning AAA and CAS.

NCT ID: NCT04097938 Completed - Healthy Clinical Trials

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

Start date: September 18, 2019
Phase: Phase 1
Study type: Interventional

This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

NCT ID: NCT04096352 Completed - Voice Disorders Clinical Trials

Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox)

VirtuVox
Start date: September 29, 2019
Phase: N/A
Study type: Interventional

Scientific literature supports that teachers are at greater risk for voice disorders than the general population. In the classroom, the teacher's voice represents the main communication tool. Optimal voice use is indispensable to ensure effective teaching and preserve the teacher's vocal health. This project investigates how virtual reality (VR) facilitates the learning of effective vocal skills and their application in real-world contexts. Based on acoustic analyses and self-assessment scales, the investigators compare 100 future teachers randomly assigned in two groups. The experimental group (n=50) receives a voice training by VR simulations and voice information. The control group (n=50) only receives voice information.

NCT ID: NCT04096248 Completed - Clinical trials for Stroke, Cardiovascular

CT (Computerized Tomography) for Late EndovasculAr Reperfusion

CLEAR
Start date: February 15, 2020
Phase:
Study type: Observational

The objective of this multicenter, retrospective, cross-sectional, chart review study is to compare outcomes (disability, complications and mortality) of patients with large vessel occlusion stroke presenting at late time window selected by either Non-Contrast CT (NCCT) only, advanced imaging with CTP (Computed Tomography Perfusion), MRI (Magnetic Resonance Imaging), or medical management. Boston Medical Center (BMC) will serve as the main data coordinating site. Fifteen additional sites will seek local IRB approval or ethics approval. The aggregated de-identified data will be analyzed comparing types of interventions and outcomes by type of imaging or medical management.