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NCT ID: NCT04216121 Recruiting - Clinical trials for Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib

LAT-FLOSI
Start date: May 10, 2021
Phase:
Study type: Observational [Patient Registry]

To determine whether in patients with EGFR mutated advanced NSCLC and osimertinib as first-line treatment, the (repeated) use of LAT to ≤ 3 OP lesions and continuation of first-line osimertinib, improves the median progression-free survival by more than 3 months (i.e. PFS2-PFS1 = >3 months).

NCT ID: NCT04206111 Recruiting - Gastric Ultrasound Clinical Trials

Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation

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

Check in gastric ultrasound for lack of stomach insufflation during preoxygenation with high-flow nasal cannulas

NCT ID: NCT04205552 Recruiting - NSCLC, Stage I Clinical Trials

Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients

NEOpredict
Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection.

NCT ID: NCT04205123 Recruiting - Sickle Cell Disease Clinical Trials

Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease

Start date: October 20, 2014
Phase:
Study type: Observational

The objective of the study is to refine our knowledge on the physiopathology of the symptoms and the complications for the patients affected by a drepanocytic syndrome. The establishment of risk factors and indicators of severity will allow to target better the patients requiring an adequate strategy in order to prevent the installation of some complications or to limit their worsening.

NCT ID: NCT04204252 Recruiting - Clinical trials for Alpha 1-Antitrypsin Deficiency

Evaluate Efficacy and Safety of "Kamada-AAT for Inhalation" in Patients With AATD

InnovAATe
Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

The current study population will consist of adult patients with congenital alpha-1 antitrypsin (AAT) deficiency who have moderate or severe airflow limitation (forced expiratory volume in 1 second 40% ≤ [FEV1] ≤ 80% of predicted) and FEV1/slow vital capacity [SVC] ≤ 70% and who have not experienced two or more moderate or one or more severe exacerbations of COPD during the past year. A total of 220 patients will be recruited, and after 4 weeks practice inhaling saline with the nebulizer, will be randomized 1:1 to inhale either 80 mg/day "Kamada-AAT for Inhalation" or a placebo with identical appearance. Patients will be treated for 104 weeks and then followed up for a further 26 weeks. Over this time there will be 13 visits to the clinical site and in addition the patients will be required to fill out a daily e-diary.

NCT ID: NCT04200768 Recruiting - Breast Neoplasms Clinical Trials

FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.

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

FATLAS is a prospective, interventional, non Investigational Medicinal Product (IMP) study aiming to characterize the micro- and macroenvironment of breast cancer according to patient adiposity in different histological and molecular subtypes. The macroscopic profiling of the patient's adiposity will be based on Body Mass Index (BMI), bioimpedance analysis and waist-to-hip ratio. Blood samples will be taken for lipidomic analyses and for hormonal and immuno assays. Microscopic profiling of adiposity and inflammation will be done on fresh frozen (FF) and Formalin-Fixed Paraffin-Embedded (FFPE) samples from the tumour resection specimen and will consist of histological characterization, immuno assays, multiplex immunohistochemistry, DNA sequencing and single nuclei RNA sequencing both in the tumour and in adjacent normal mammary tissue.

NCT ID: NCT04194073 Recruiting - Clinical trials for Pulse Oximeter Calibration

NightOwl SpO2 Calibration Study

NOSCS
Start date: December 7, 2019
Phase: N/A
Study type: Interventional

Calibration of a software module that computes Oxygen saturation(SpO2) based on photoplethysmography (PPG) traces acquired by the NightOwl reflectance-based PPG sensor which is placed on the finger. The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)

NCT ID: NCT04191304 Recruiting - Clinical trials for Hypereosinophilic Syndrome

A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

NATRON
Start date: July 20, 2020
Phase: Phase 3
Study type: Interventional

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. Patients will continue to be recruited until approximately 38 patients have had their first HES worsening/flare during the DB treatment period at which point the data cut-off for the primary database lock (DBL) will occur. Treatment allocation will remain blinded until the primary DBL. After the study is unblinded for the primary analysis, patients and investigators will remain blinded to patients' individual treatment allocations until after the final patient completes the DB treatment period. The primary analysis will only include data from the DB treatment period of the study. A follow-up analysis will be performed once all patients have the opportunity to complete the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.

NCT ID: NCT04189978 Recruiting - Allergic Disorder Clinical Trials

Impact of Microbial Exposure of the Habitat at the Time of Birth on the Development of Allergic Diseases.

Start date: November 12, 2019
Phase:
Study type: Observational

In 2001-2002, a longitudinal study on the risk of atopic sensitization in children was conducted by the Pneumo-Allergology and Pediatrics departments of the CHU Saint-Pierre Hospital and at the Neonatology Department of the Queen Fabiola Children's University Hospital (HUDERF). The aim of the study was to study bacteria and endotoxins in airborne dust in Brussels homes in order to evaluate their impact on the development of allergic diseases in newborns. Between December 2000 and August 2002, 114 children (67 from HUDERF and 47 from CHU St-Pierre) were included in the study. These were eutrophic children without acquired pathology or known genetics. Simultaneously a microbial habitat assessment was performed based on a detailed description and on endotoxin assays in the airborne and deposited dust (mainly mattress).These data can be used to define habitats with high or low contamination.Samples for microbial analyzes (Gram positive and negative and mold) were also carried out. Preliminary results suggested: 1. A protective effect of airborne dust endotoxins on the risk of developing atopic dermatitis in children at 6 and 12 months of life, 2. An effect of endotoxins promoting the occurrence of wheezing in children after 6 months. In this current, new study, the investigators will recontact the children who were included in the 2003 study. The goal is to evaluate them clinically and allergically and associate the risk of sensitization / allergic diseases with the microbial exposure of the habitat, measured during the neonatal period. Siblings and parents who were exposed during the same period will also be evaluated.

NCT ID: NCT04188743 Recruiting - Clinical trials for Resistance Bacterial

Decolonization of Gram-negative Multi-resistant Organisms (MDRO) With Donor Microbiota (FMT)

DEKODON
Start date: December 18, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all. The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.