Paris 19, France
Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
Phase
N/ASpan
315 weeksSponsor
Centre Hospitalier Intercommunal CreteilCharenton-le-Pont
Recruiting
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Phase
3Span
255 weeksSponsor
Dizal PharmaceuticalsSaint-Mande
Recruiting
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus
The RODEO 1 study is designed to determine the safety and efficacy of partial oral treatment of IE compared with traditional full-length parenteral treatment. Our primary objective is to demonstrate that in patients with left-sided multi-susceptible Staphylococcus who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of rifampicin and fluoroquinolones between Day 10 and Day 28 after initiation of the IV antibiotic treatment, is not inferior to the continuation of the conventional IV antibiotic treatment regarding to treatment failure within 3 months after the end of antibiotic treatment. Nationwide, noninferiority, multicenter, randomized, controlled, open-label trials. Randomisation will only be offered to patients who have received at least 10 days of IV conventional antibiotic treatment of IE, and fulfil the inclusion criteria. Randomisation will take place between Day 10 and Day 28 after initiation of parenteral antibiotic therapy or valvular surgery, thus ensuring to have at least 14 days of oral therapy in the experimental group. Patients will be eligible whether they have undergone valvular surgery or not. This will imply that surgery procedure prior to randomisation will be heterogeneous, but randomisation will be stratified on the requirement of valvular surgery as part of the treatment of the current episode of IE or not.
Phase
3Span
448 weeksSponsor
University Hospital, ToursSaint-Mande
Recruiting
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus
The RODEO 2 study is designed to determine the safety and efficacy of partial oral treatment of IE compared with traditional full-length parenteral treatment. Our primary objective is to demonstrate that in patients with left-sided multi-susceptible Streptococcus-Enterococcus IE who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of amoxicillin between Day 10 and Day 28 after initiation of the IV antibiotic treatment, is not inferior to the continuation of the conventional IV antibiotic treatment regarding to treatment failure within 3 months after the end of antibiotic treatment. Nationwide, noninferiority, multicenter, randomized, controlled, open-label trials. Randomisation will only be offered to patients who have received at least 10 days of IV conventional antibiotic treatment of IE, and fulfil the inclusion criteria. Randomisation will take place between Day 10 and Day 28 after initiation of parenteral antibiotic therapy or valvular surgery, thus ensuring to have at least 14 days of oral therapy in the experimental group. Patients will be eligible whether they have undergone valvular surgery or not. This will imply that surgery procedure prior to randomisation will be heterogeneous, but randomisation will be stratified on the requirement of valvular surgery as part of the treatment of the current episode of IE or not.
Phase
3Span
448 weeksSponsor
University Hospital, ToursSaint-Mande
Recruiting
A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
Phase
N/ASpan
221 weeksSponsor
PfizerSaint-Mande
Recruiting
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
It's a cross-sectional, monocenter, prospective, open-label, non-randomized case control study to collect saliva and serum samples as part of the patient's routine care in oral medicine department to form a biological collection. Patients will be recruited in the oral medicine department of AP-HP Charles Foix hospital (Ivry/Seine) by periodontists in 2 groups (CASES: Group 1 for children with DS/T21 divided into 2 subgroups according the periodontal health, and CONTROLS: Group 2 divided into 4 subgroups according to the systemic and periodontal health) Inclusion period is 12 months. There is no specific follow-up due to the research. Assessment criteria: - Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by flow cytometry. - Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within blood neutrophils, during periodontal health, gingivitis and periodontitis.
Phase
N/ASpan
105 weeksSponsor
Assistance Publique - Hôpitaux de ParisIvry-sur-Seine
Recruiting
Validation of a Digital Multidimensional Assessment Tool for the Elderly in Geriatric Consultations
The use of digital tools on tablets to gather information from patients is on the increase. Numerous computerised tools exist for identifying health problems and have been validated in the medical world. However, there are currently no digital tools adapted to the elderly in a consultation context. In this project, the investigators want to carry out a cross-sectional observational study to assess the validity of a multidimensional assessment tool on a tablet, self-administered by patients or carers, and also the appropriateness of using it with these groups. Objectives Multidimensional assessment tools have the advantage of enabling several issues to be addressed systematically. In this research, the investigators want to assess the validity of a multidimensional assessment tool in digital format in a population of elderly people and carers. To do this, the investigators intend to use scales that already exist and are usually used in paper format: the ADL and IADL for dependency, the Mini MNA for nutrition, the Cornell and GDS-15 for depression, the mini Zarit for estimating the burden on carers and the Cetaf score and short FES-I for the risk of falling. These assessment tools have been adapted to digital format and brought together to form a comprehensive multidimensional assessment tool. The investigators' first objective was to assess the validity of this set of scales in digital format compared with their original paper versions, but the investigators also want to measure the acceptability of this assessment tool in a geriatric population and among family carers. In addition, the investigators plan to assess the adaptability of this tool and its compatibility in a geriatric consultation setting. Finally, the investigators want to measure doctors' satisfaction with the collection of this information, as a time-saving tool for these professionals. Methods Eighty patients and eighty carers will be included in this study, recruited from the geriatric consultation service (outpatient geriatrics department) at Charles Foix Hospital. These will be people aged over 65, and family carers if it is not possible to carry out the test on a self-administered basis. To do this, the investigators are planning a quantitative study to compare the scores obtained by the digital version of the test with the data described by the doctors in the reports, and in particular the same scales systematically filled in by the medical profession. In addition, the investigators want to analyse what users say and assess their experience of practical issues (grip, legibility, impression of confidentiality when filling in the form in the waiting room, etc.). Outlook A multi-theme self-questionnaire assessment of elderly people and their carers waiting for a consultation would save professionals time (in terms of completion time and calculation of results), make data more secure, save paper and provide a complete and systematic scan of a number of potentially serious risks.
Phase
N/ASpan
35 weeksSponsor
RIVAGESIvry-sur-Seine
Recruiting
Healthy Volunteers
Periodontitis and Inflammation: Study on Biological Samples
It's a cross-sectional, monocenter prospective, open-label, non randomized case control study to collect tissue, crevicular, salivary, and serum samples as part of the patient's routine care in oral medicine departments to form a biological collection. The samples and the clinical data of the patients. Patients will be recruited in the oral medicine departments of AP-HP Charles Foix hospital (Ivry/seine) by periodontists in three groups (Cases : Group 1 : Gingivitis, Group 2 : Periodontitis, and Controls = healthy periodontium. All patients will require surgical care). The time-line of the research is consistent with the usual patient management in oral medicine departments. Inclusion period is 36 months. There is no specific follow-up due to the research. Gingival tissue sampling during surgery of patients will be performed after their inclusion. Assessment Criteria : 1. Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by imaging on sections. 2. Identification by immunohistofluorescence (on tissues) of the expression of matrix proteins described as regulating neutrophil function, and search of co-location between these proteins and certain neutrophil subtypes. 3. Identification by immunohistofluorescence (on tissue) of key bacteria of oral dysbiosis in periodontitis, and search for co-localization between these bacteria and certain neutrophil subtypes. 4. Assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within tissue neutrophils during periodontal health, gingivitis and periodontitis. 5. Differentiation and activity of osteoclasts in co-culture with isolated oral /blood neutrophils in patients.
Phase
N/ASpan
159 weeksSponsor
Assistance Publique - Hôpitaux de ParisIvry-sur-Seine
Recruiting
Healthy Volunteers
Oral Health and Wilson's Disease: SOMAWI
The comparaison between the three groups is based on evaluation criteria wich is CAOD index of caries severity (developed by Klein and Palmer in 1940) counting the number of permanent teeth with caries (evolving to include non-cavitary caries) (C), absent due to caries (A) and filled (O) in an individual. The maximum score is 28 (third molars are not taken into account). The index is obtained from clinical examination and panoramic dental imaging.
Phase
N/ASpan
181 weeksSponsor
Fondation Ophtalmologique Adolphe de RothschildIvry-sur-Seine
Recruiting
Healthy Volunteers
Access HBV Assays - European Union (EU) Clinical Trial Protocol -
Sensitivity to final status on presumed HBV serological marker positive subjects will be calculated. Specificity will be calculated from hospitalized patients and blood donors specimens. False Initial Reactive Rate will be calculated on fresh hospitalized patient samples for Access HBsAg assay only (Qualitative).
Phase
N/ASpan
346 weeksSponsor
Beckman Coulter, Inc.Ivry-sur-Seine
Recruiting