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  • Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples

    Group A streptococcus (GAS) is found in 20% to 40% of cases of childhood pharyngitis; the remaining cases are viral. Streptococcal pharyngitis ('strep throat') deserves antibiotics, while these are not indicated in viral cases. Because signs and symptoms of streptococcal and viral cases overlap, most guidelines recommend relying on a diagnostic test to identify Group A streptococcus to select who should receive antibiotics. In most settings, the first-line test to detect Group A Streptococcus is a rapid antigen detection test based on a throat swab, and the reference standard to identify streptococcal cases is throat culture. Recently, new rapid tests were developed. They use molecular techniques, such as rapid PCRs or LAMP, based on throat swabs. We hypothesize that these new molecular tests are sensitive enough to be performed on saliva swabs instead of throat swabs. Collecting saliva is less invasive and could be done by personnel with limited training.

    Phase

    N/A

    Span

    109 weeks

    Sponsor

    Centre Hospitalier Intercommunal Creteil

    Saint-Ouen

    Recruiting

  • The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis

    The main objective of the study will be to quantify the rate of subjects seeking help in our units meeting the criteria of subject with an ultra-high risk of psychosis (UHR). Secondary objectives: - Observe the transition rate of these high risk patients at one year. - Study the socio-demographic and general psychopathology profiles of 12 - 25 year olds using the services of CMP, CASADO, mobile team and RCL. - Monitor the development of school and professional integration, the overall functioning and self-esteem of subjects at six months and one year.

    Phase

    N/A

    Span

    82 weeks

    Sponsor

    Januel

    Saint-Denis

    Recruiting

  • Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department

    Phase

    3

    Span

    105 weeks

    Sponsor

    University Hospital, Rouen

    Saint-Ouen

    Recruiting

  • Survey on Epidemiology of Hypoparathyroidism in France

    Very few data has been published on the epidemiology of hypoparathyroidism worldwide. None exists specifically in France. Hypoparathyroidism could led to complications: e.g. symptomatic hypocalcemia, calcifications (brain, eye and other soft tissues), nephrolithiasis/nephrocalcinosis, renal insufficiency. Here,the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

    Phase

    N/A

    Span

    796 weeks

    Sponsor

    European Georges Pompidou Hospital

    Saint-Ouen

    Recruiting

  • Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease

    Phase

    2/3

    Span

    222 weeks

    Sponsor

    Vertex Pharmaceuticals Incorporated

    Saint-Ouen

    Recruiting

  • Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

    Phase

    2/3

    Span

    358 weeks

    Sponsor

    CSL Behring

    Saint-Ouen

    Recruiting

  • Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

    The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF). VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm. No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study. The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively. The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.

    Phase

    N/A

    Span

    148 weeks

    Sponsor

    Volta Medical

    Saint-Denis

    Recruiting

  • Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    Nantes University Hospital

    Saint-Denis

    Recruiting

  • Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"

    Research involving non-interventional humans. Selection and inclusion of patients by CHSD investigators. Collection of clinical data by investigators and CHSD URC staff. Biochemical and hematological measurements by the CHSD medical biology laboratory for "care" samples Pseudonymization of 4 mL "research" samples by the URC then fractionation of the samples by 1 mL, and storage at -80°C within the medical biology laboratory of the CHSD. Transport of samples at -80°C to team 1 of Dr Baudin-Creuza (Créteil). Preparation of genomic DNA from a 1 mL fraction then α and β globin genotyping by Dr Pissard. Measurement of the AHSP concentration from the other fractions. Comparison of the AHSP concentration according to the group of subjects, and with the different parameters, then correlation analysis

    Phase

    N/A

    Span

    98 weeks

    Sponsor

    Centre Hospitalier de Saint-Denis

    Saint-Denis

    Recruiting

  • SENOVIE France - Therapeutic Mobility and Breast Cancer

    Background In 2023, with 61,214 new cases diagnosed in France, breast cancer accounts for 33% of women's cancers and is the most common cancer in women. With an estimated prevalence in 2017 of 913089 people, studies also suggest an increase in the standardized incidence rate for several years, from 72.8 per 100,000 in 1990 to 99.2 per 100,000 in 2023. This increase is partly explained by the implementation of screening campaigns that promote the early detection of new cases, but also by the presence of risk factors that are responsible for a large proportion of breast cancers. Studies on social inequalities in the face of breast cancer highlight several realities. Indeed, while breast cancer is considered one of the cancers with a better prognostic life due to the net survival rate of 88% observed five years after diagnosis, studies show that these rates vary by age and that women from lower social classes have a higher risk of death than women from privileged social classes. In addition, although immigrant women, especially those from sub-Saharan Africa, face several health problems and often live in precarious situations in France, few studies have documented the situation of these women with breast cancer compared to women born in France. The few studies carried out highlight inequalities in access to breast cancer screening and a life after breast cancer marked by significant social and administrative precariousness. Thus, it is possible to think that, in the face of breast cancer, the trajectories of women born in sub-Saharan Africa could be different from those of women born in France. For example, it is possible that immigrant women have a different age of cancer onset than non-immigrant women or that they encounter greater difficulties in accessing care. The SENOVIE France project was designed to fill this knowledge gap. It aims to better understand the impact of breast cancer on the life trajectories of women born in France and women born in sub-Saharan Africa. Objectives The SENOVIE France survey aims: - To understand how breast cancer (diagnosis, treatment, and breast reconstruction) impacts women's lives that are already affected by migration in many spheres (i.e., social consequences of breast cancer on spheres like family or occupation/financial situation). - To study the therapeutic itineraries (including self- reconstruction) of immigrant women living with breast cancer in the greater Paris area and understand their social determinants. - To observe how gender can shape women's medical and social outcomes in a migration context. Methodology The SENOVIE France survey is a mixed-methods survey with two components: a quantitative component and a qualitative component. Quantitative component The quantitative component is based on a life event survey, a methodology successfully used in the field of HIV/Hepatitis B among immigrants in the greater Paris area by several members of this research. This innovative methodology has the great advantage of collecting longitudinal data while avoiding attrition which is very frequent in prospective cohorts among disadvantaged populations: women are surveyed one time and are asked retrospectively about their past trajectories. A close-ended question CAPI questionnaire and a biographical grid paper where the interviewer reports key elements and dates will be used for data collection. The biographical grid paper was shown to help to minimise memory biases because the interviewees can use both dates and age to remember the order of events and can place elements in perspective with one another (for example, a woman can ignore at what date she had access to medical insurance, but she would remember it occurred during her second pregnancy). This methodology has shown robustness in tracing back life and health trajectories. This survey aims to recruit about 1000 women, including 500 women born in France and 500 women born in sub-Saharan Africa. During the twelve months of the data collection, a CAPI patient questionnaire, a biographical grid paper (completed by interviewers recruited and trained by INED) and a medical questionnaire (completed by clinical researchers from partner hospitals) will be used to collect the following data: The patient questionnaire and the biographical grid include the following modules: 1. retrospective on the whole life (residential history, professional history), 2. history of relationships and children, 3. nationality, arrival in France and stay (for immigrant women), 4. health coverage, 5. violences, 6. breast cancer (diagnosis, treatment, and impact on women's life), 7. Covid period, 8. economic consequences, 9. health, sexuality and well-being. The collection will be carried out in the context of a face-to-face interview. Within each health services, eligible patients will be identified by the healthcare professional during (or before) the consultation. The survey will be offered by the healthcare professional to all eligible patients. Patients who will agree to participate will be referred to the interviewers. Patients will be able to agree to participate in the survey immediately after their consultation or agree to participate by appointment. Those who will agree to participate by appointment will agree on a date for taking the questionnaire with the interviewers. In both cases, the questionnaire will be administered in the premises of the project's hospital partners (Saint-Louis University Hospital AP-HP ; Delafontaine Hospital Saint-Denis ; Robert Ballanger Hospital Aulnay-sous-Bois) in offices that guarantee the confidentiality of the interview. The individual questionnaires will be entered in real time on an INED secure LimeSurvey server. The biographical grids will be collected on paper before being entered by a dedicated operator on the same LimeSurvey server. The medical questionnaire contains questions about the characteristics of the cancer and the treatments followed by women. It will be supplemented by hospital staff from partner centres. The entry will be done on the IRD's REDCap secure server. In terms of statistical analysis, descriptive statistics will be used to precisely describe the medical status, social characteristics, and living conditions of women born in France and women born in Sub-Saharan Africa living with breast cancer in the greater Paris area. These statistics may also be age-standardized if, as expected, women from sub-Saharan Africa are younger than their native-French counterparts. To measure the social consequences of breast cancer diagnosis and treatments, specific statistical methods for longitudinal data (sequence analysis, Cox models, discreet-time logistic regressions) that allow to take different temporalities into account (time since migration, since diagnosis, since treatment, etc.) will be used. A specific attention will be paid to how healthcare trajectories may have been impacted between 2020 and 2021 by the sanitary crisis, and also to examine whether all women were affected in the same way (missing medical follow-ups, delayed surgeries). Special attention will also be paid to the social determinants and social impacts of breast reconstruction. Qualitative component The objective of this qualitative component is to describe in depth the way in which women's health, social and migratory trajectories are articulated, and their involvement in the care of women born in Sub-Saharan Africa in French health services. This section aims to answer the following questions: which immigrant women circulate and under what conditions? What are the challenges and obstacles participants face? What are the administrative, material and social difficulties participants face? What levers can be activated ? To remove these obstacles, which actors can immigrant women rely on? What are the professional, family, conjugal, emotional and physical experiences of these women? To answer these questions, qualitative interviews will be conducted with women born in sub-Saharan Africa. The goal is to carry out about forty interviews in the greater Paris area. The exact number may vary depending on the principle of data saturation. The interviews will be recorded, pseudonymized and transcribed. They will be stored on a secure NextCloud server at Ceped. The interviews will be analyzed with a comprehensive approach that aims to analyze the experiences as they were lived by the participants. Perspectives and expected results This research will document the social and health trajectories of women with breast cancer and followed in certain hospitals in the greater Paris area with a comparative aim. It will provide scientific knowledge on the circumstances of cancer diagnosis in women born in France and those born in sub-Saharan Africa, on the experience of the disease and its consequences on different aspects of women's lives (economic, entourage, sexuality, couples, etc.). This research will raise the awareness of patients' associations and perhaps help them to develop specific lines of action for immigrant women and to lobby political decision-makers to promote their access to care. These results could thus contribute to the improvement of medical and psychosocial care for women living with breast cancer.

    Phase

    N/A

    Span

    53 weeks

    Sponsor

    Institut de Recherche pour le Developpement

    Saint-Denis

    Recruiting

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