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NCT ID: NCT05062642 Recruiting - Meningitis Clinical Trials

Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

Adult-BMS
Start date: August 26, 2021
Phase:
Study type: Observational

Meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. Many pathogens can cause meningitis, the severity of which varies greatly. Patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis. Viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. Bacterial meningitis is less frequent but more serious.The current public health objective is to save antibiotics. Investigator hypothesizes that the BMS score can be used to exclude bacterial meningitis in the emergency department in an adult European population of patients with suspected bacterial meningitis.

NCT ID: NCT05062109 Recruiting - Osteoarthritis Clinical Trials

Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

PRE4OS
Start date: June 16, 2021
Phase: N/A
Study type: Interventional

The main objective of this multicentric, prospective and interventional study is to assess the feasibility of multimodal prehabilitation in patients aged 75 years or older with surgical indication for coxarthrosis or severe gonarthrosis

NCT ID: NCT05062031 Recruiting - Myopia Clinical Trials

Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops

ATROSMART
Start date: October 19, 2021
Phase: N/A
Study type: Interventional

Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation. Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses. The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.

NCT ID: NCT05061550 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

NeoCOAST-2
Start date: April 14, 2022
Phase: Phase 2
Study type: Interventional

The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

NCT ID: NCT05061420 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)

Start date: October 8, 2021
Phase: Phase 2
Study type: Interventional

The is a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Substudy 1-Cohort A1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who are treatment-naïve for recurrent and/or metastatic (R/M) disease. Substudy 4-Cohort B1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen. Substudy 5-Cohort B2 aims to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen & cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.

NCT ID: NCT05061134 Active, not recruiting - Melanoma Clinical Trials

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

MONETTE
Start date: August 11, 2022
Phase: Phase 2
Study type: Interventional

Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and safety/tolerability of ceralasertib, when administered as monotherapy and in combination with durvalumab in participants with unresectable or advanced melanoma and primary or secondary resistance to PD-(L)1 inhibition.

NCT ID: NCT05060939 Completed - COVID-19 Clinical Trials

SARS-CoV-2 Infection in COVID-19 Vaccinated Patients

COVID-IVAC
Start date: August 20, 2021
Phase: N/A
Study type: Interventional

Vaccination of the population is crucial in the fight against the COVID-19 pandemic. Although most available vaccines have an estimated efficacy against symptomatic infection of 65-95%, this can be significantly reduced if the patient has co-morbidities such as immunosuppression or if the full vaccination schedule is not followed. Infection with SARS-CoV-2 variants, carrying mutations, notably on the spike protein, may also be associated with escape from immunity acquired by vaccination. Indeed, in vitro studies have shown a decrease in sensitivity to neutralizing antibodies acquired after vaccination or even after infection for certain variants such as variant B.1.351 (beta variant according to the WHO, first detection in South Africa) or variant B.1.617.2. (delta variant according to the WHO, first detection in India). On the other hand, cases of COVID-19 following a full vaccination regimen have recently been reported. With the increasing detection of new variants and in the context of increasing vaccination coverage of the population, one of the priority missions of the National Reference Centre (NRC) for respiratory infection viruses is to clinically and virologically investigate all cases of infection in vaccinated patients. The main objective is to determine whether a particular variant is over-represented in vaccinated patients with an infection. The secondary objective is to study the humoral immune response in COVID-19 vaccinated patients with and without SARS-CoV-2 infection.

NCT ID: NCT05060874 Completed - Clinical trials for Age-Related Sarcopenia

Gripwise® Versus JAMAR®

HANDGAGES
Start date: September 1, 2021
Phase:
Study type: Observational

It is recommended to screen ageing patients for sarcopenia, due to the increased risk of morbimortality if detected positive. According to the consensus of the European Working Group on Sarcopenia in Older People, the diagnosis of sarcopenia is based, among other things, on grip strength measurement. Our study will compare the performance of the new GRIPWISE digital device with the mechanical dynamometer JAMAR, the gold standard currently used to assess the grip strength. We propose to evaluate it in an elderly hospitalized population where the prevalence of sarcopenia is likely to be high due to the high prevalence of various chronic illness, notably oncological and cardiological ones. This cross-sectional study will include 348 patients.

NCT ID: NCT05060718 Completed - Clinical trials for Ventilator Associated Pneumonia

HOspital NEtwork STudy - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies

HONEST-PREPS
Start date: May 20, 2020
Phase:
Study type: Observational

Hospital Acquired and Ventilator Associated Pneumonia (HAP/VAP) pose a significant burden to patients admitted to the Intensive Care Unit (ICU). Reported incidence ranges from 10-16% in all ICU patients (including HAP and VAP) and around 20-30% in ventilated patients (VAP). Patients with HAP/VAP have a high mortality rate. The estimated attributable mortality of VAP is 6-13%. Randomized Controlled Trials (RCTs) are the gold standard for evaluating medical interventions, but are difficult to perform in this population. Several preventive and therapeutic treatment options are being developed that will require evaluation in phase-III trials. These trials are challenging due to the relatively low incidence of the outcome (e.g. HAP/VAP) or of the domain under study (e.g. specific antibiotic resistant infections) and the requirement of informed consent in critically ill patients. There is a need for a well-organized and well-trained international RCT network that enables efficient execution of a series of RCTs in this population. The aim of the current study is to set up an infrastructure to prospectively enroll patients at risk of HAP/VAP in ICUs in several European countries. Site personnel will be trained to obtain a GCP (Good Clinical Practice) certification (if not already done), to timely identify and enroll patients at risk of HAP/VAP, to timely identify occurrence of HAP/VAP, collect informed consent forms, collect source data, enter data into a clinical database, and use a dedicated system to reply to queries. Site sample collection, processing, identifying the causative organism, and antibiotic susceptibility testing will be validated and adapted if required where possible. Where site infrastructure and regulations allow, the possibility of automated data collection of included participants will be explored to ensure sustainability of the future platform. Furthermore, collected data will be used to inform future diagnostic, preventive and therapeutic trials. E.g. they may support assumptions in sample size calculations and expected number of enrolled participants, they may help in prioritizing interventions, or they may be used in simulations of adaptive trials to optimize decision rules.

NCT ID: NCT05060432 Active, not recruiting - Lung Cancer Clinical Trials

Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

TIG-006
Start date: September 6, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.