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Found 22 Actively Recruiting clinical trials

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Actively Recruiting

Encephalitis and myelitis involve inflammation or infection of the brain or spinal cord. In Guadeloupe, many cases of these acute infectious conditions do not have an identified cause despite suspicion of infection. This research aims to use next-generation sequencing NGS to better identify the germs involved, especially since traditional methods often fail to find the pathogen. Understanding the causes is important because these conditions have serious health impacts and some may be specific to tropical regions like Guadeloupe. The study is observational and will prospectively examine patients diagnosed with encephalitis or myelitis at the University Hospital of Guadeloupe. It includes diagnostic methods such as NGS when initial tests do not reveal the cause. The study will collect data on clinical, imaging, and laboratory findings over time, including follow-ups at baseline, 15 days, 3 months, and 12 months. Patients will undergo neuroimaging, bacteriological and biochemical tests, and neuropsychological assessments during these periods. Participants will be monitored with several evaluations including pathogen identification, neurological exams, and brain scans at multiple time points up to one year. Researchers will track the presence of neurotropic pathogens and study clinical and neuropsychological outcomes to improve understanding of these serious diseases. The study will provide detailed epidemiological data and long-term outcome information, with total participation lasting up to 12 months.

Age: 28Days +All Genders
1 location
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Actively Recruiting

Chronic liver diseases affect over 800 million people worldwide and cause about 2 million deaths each year. Early diagnosis and prediction of disease progression remain major challenges, as current blood markers and panel tests lack sensitivity and specificity. This research focuses on albumin post-translational modifications PTM as potential early biomarkers that may indicate future liver damage and help predict disease progression in patients with chronic liver disease. The study will recruit 756 patients with compensated fibrosis from six university hospitals and follow them for up to three years. Blood samples will be taken at the start and during follow-up visits at one, two, and three years, either through additional tubes added to routine samples or using leftover samples. These will be analyzed centrally to assess albumin isoform profiles and ligand-binding capacities using the Serum Enhanced Binding SEB test. Participants will have no extra visits beyond their usual care appointments. Data including blood results and medical records will be collected at each visit. Researchers will evaluate the ability of albumin modifications and the SEB test to predict liver disease progression, monitor changes over time, and confirm characteristic albumin patterns related to liver injury. The study aims to improve liver disease diagnostics and patient care by validating these novel biomarkers.

Age: 18Years +All GendersPhase Not Applicable
7 locations
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Actively Recruiting

Researchers are investigating the possible link between exposure to chlordecone, a persistent organochlorine pesticide formerly used in the French West Indies, and female fertility. This study focuses on women who are consulting for couple infertility in Guadeloupe. Chlordecone has known estrogenic and progestagenic effects and has been shown in animal studies to impair ovulation and reduce ovarian reserve, but its impact on human female fertility has not been studied before. This observational study will measure levels of anti-mullerian hormone AMH, a marker of ovarian reserve, and analyze their association with different levels of chlordecone exposure. Additional assessments will include counting antral follicles within the menstrual cycle and evaluating other environmental exposures, including persistent organic pollutants. The study will also examine the relationship between chlordecone exposure and the risk of main causes of female infertility, as well as outcomes after assisted reproductive technology treatments over a two-year period. Participants will undergo AMH measurement during their assisted reproductive technology assessment and have antral follicle counts done between days 2 and 4 of their spontaneous menstrual cycle. Researchers will collect baseline exposure data and follow participants for up to two years to monitor fertility treatment outcomes. This study will help clarify how environmental factors like chlordecone and the vaginal and endometrial microbiome might affect female fertility in this population.

Age: 18Years - 39YearsFEMALE
1 location
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Actively Recruiting

Researchers are studying the progression and development of prostate cancer, which varies greatly between individuals based on genetic, clinical, and environmental factors as well as ethno-geographic origins. The goal is to identify factors that influence how the disease evolves, including risks of complications and treatment responses. This knowledge aims to support better treatment choices and improve prevention and screening, especially in high-risk populations. The study involves two groups of newly diagnosed prostate cancer patients from Guadeloupe and Rennes, representing different ethno-geographic backgrounds. Patients will be included before starting treatment and followed over time. Data collection includes questionnaires about lifestyle, medical and occupational history, and socio-demographic information. Biological samples like saliva, urine, and blood will be taken for genetic and environmental analysis. Patients will receive standard care, with additional sample collections for detailed biological studies. Participants will have regular follow-up visits at diagnosis and at 1, 2, 5, and 10 years after inclusion and treatment start. During these visits, clinical data, anthropometric measurements, and blood pressure will be recorded. Questionnaires will assess quality of life and other health factors. The study will measure associations between various determinants and health events related to prostate cancer progression and other health issues over time. This long-term monitoring aims to improve understanding of the disease course and outcomes.

Age: 18Years +MALEPhase Not Applicable
2 locations
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Actively Recruiting

Pemphigus diseases are serious, chronic autoimmune conditions that cause blistering due to the immune system attacking certain skin proteins. The two main types studied here are pemphigus vulgaris and pemphigus foliaceus. Researchers are evaluating a new personalized maintenance therapy involving rituximab infusions guided by antibody levels to see if this approach can better prevent disease relapses compared to the standard treatment. This is a phase 4 randomized study conducted by the University Hospital, Rouen, building on previous rituximab trials that led to regulatory approvals. Participants in the trial will receive initial treatment with rituximab and oral prednisone following French guidelines, with rituximab given at Day 1, Day 14, Month 12, and Month 18. One group will receive this standard regimen, while the experimental group will have their treatment adapted based on anti-desmoglein antibody levels. Additional rituximab infusions may be given at Month 6 or later if antibody levels remain high or increase, with up to two extra infusions per year allowed during the study. During the study, participants will be regularly monitored through blood tests for antibody levels and blood cells every three months for up to 7.5 years. Researchers will assess the number of disease relapses, time to relapse, duration of remission, quality of life, and rituximab exposure. The study will also track the total dose of rituximab and record safety outcomes. This long follow-up aims to understand if personalized maintenance with rituximab can reduce relapses and the need for corticosteroid treatment.

Age: 18Years - 80YearsAll GendersPhase 4
34 locations
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Actively Recruiting

This research aims to improve genetic counseling by classifying gene variants found in families with a history of hereditary cancers, especially breast and ovarian cancer. Initially focused on BRCA1 and BRCA2 genes, the study now includes multiple genes from a large French oncogenetics database, covering thousands of families and variants. The goal is to better understand which gene variants are linked to cancer risk and to refine how these variants are classified for clinical use. Participants include index cases carrying specific gene variants and their family members. The study collects saliva samples from relatives to test for the presence of these variants, particularly those classified as uncertain significance class 3, likely pathogenic class 4, or hypomorphic pathogenic class 5. Genetic analyses are performed by specialized laboratories, and data from multiple families is combined to assess how these variants co-segregate with cancer occurrence. Throughout the study, researchers analyze genetic data using statistical models to estimate the likelihood that certain variants cause cancer. They use anonymous results for overall variant classification and share findings with families when variants are found to be pathogenic. This helps guide genetic counseling, possible preventive measures, and clinical management. The study spans up to 15 years and continuously updates classification methods and clinical recommendations based on new data.

Age: 18Years +All GendersPhase Not Applicable
62 locations
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Actively Recruiting

This research aims to compare the cost-effectiveness of focal high-intensity focused ultrasound F-HIFU treatment versus radical prostatectomy RP in men with favorable intermediate risk localized prostate cancer. The study focuses on patients with non-treated prostate cancer characterized by specific Gleason scores and tumor visibility on MRI, evaluating both treatments from a healthcare system perspective. It is a randomized, pragmatic clinical trial conducted across multiple centers, aiming to provide insights into cancer control and side effect profiles such as urinary, sexual, and digestive outcomes. Participants will be randomly assigned to receive either F-HIFU using the Focal-Oneae device under local or general anesthesia or undergo a radical prostatectomy performed via open, laparoscopic, or robot-assisted surgery under general anesthesia. Randomization is stratified by center and initially equal but later adjusted to a 21 ratio favoring F-HIFU. Treatment is followed by regular monitoring up to 48 months, with data collection enhanced using national health databases to assess costs, mortality, and cancer control without additional patient visits. During the study, men will undergo assessments including urinary and sexual function evaluations, quality of life questionnaires, and survival monitoring at multiple timepoints up to 48 months. The primary outcome focuses on the cost-utility ratio at 24 months, with secondary outcomes including survival rates, preserved life costs, and treatment-related quality of life. Participants are closely followed through clinical visits and data linkage, ensuring comprehensive evaluation of both treatment approaches over time.

Age: 50Years - 75YearsMALEPhase Not Applicable
20 locations
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Actively Recruiting

Healthy Volunteer

This research aims to describe HIV prevention practices in over 23 HIV sites across France, including overseas locations. It focuses on various aspects such as HIV screening, sexually transmitted infections STI screening, hepatitis screening, and the use of post-exposure prophylaxis PEP and pre-exposure prophylaxis PrEP. The study is observational and seeks to collect detailed information about HIV prevention measures in these diverse settings. Participants in this cohort study are observed based on their attendance for HIV prevention services including HIV, hepatitis, and STI screenings, as well as their use of PEP or PrEP. The study does not involve investigational treatments but follows participants over time to gather data on these prevention practices according to French national guidelines. During the study, researchers will track the number of people enrolled for HIV prevention over about one year, as well as proportions using PrEP and PEP and undergoing hepatitis and STI screenings. They will also monitor the incidence of sexually transmitted infections and hepatitis. Participants will provide informed consent and their progress will be observed without altering their usual care or treatment.

Age: 18Years +All Genders
31 locations
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Actively Recruiting

Healthy Volunteer

Researchers are investigating how the S100B protein blood levels vary among individuals with different ethnic backgrounds, particularly in Guadeloupe where the majority have a Black phenotype. This study aims to confirm if physiological levels of S100B protein differ by skin phenotype, which is important because current thresholds for using S100B to reduce CT scans in minor traumatic brain injury may not accurately apply to this population. Prior studies suggest higher S100B levels in Black individuals, but data is limited and variable. The study will involve hospital staff from the University Hospital of Guadeloupe and the Hospital of Basse-Terre who meet eligibility criteria. Participants will provide informed consent, complete an anonymous questionnaire about their ethnicity, age, sex, and weight, and provide a blood sample. This sample will be analyzed at the hospital laboratory to measure the S100B protein level and assess its correlation with ethnicity and skin phototype. Participants will be involved in completing questionnaires and blood collection during the study. Researchers will measure baseline S100B protein levels and analyze these in relation to ethnicity and skin phototype. The study is observational, and no treatments or interventions are administered. The information gathered will help improve the use of S100B testing in clinical practice for populations with diverse ethnic backgrounds, over the course of the study period ending in August 2025.

Age: 18Years - 65YearsAll Genders
2 locations
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Actively Recruiting

Researchers are investigating the effects of exposure to chlordecone, an organochlorine insecticide, on child development in the French West Indies, focusing on children reaching the peripubertal age. This study follows children born to mothers who participated in the TIMOUN cohort between 2004 and 2007, aiming to understand how environmental pollution may impact cognitive and pubertal development. The research addresses concerns about the sensitivity of children and adolescents to environmental toxins and follows recommendations from health authorities and national plans. The study involves a follow-up of children born alive in the TIMOUN cohort who are now at peripubertal age. Researchers will conduct clinical examinations, collect questionnaires from parents about the childs health and lifestyle, and measure physical parameters such as height, weight, and cardiovascular function. Cognitive tests assessing verbal comprehension, perceptual reasoning, and working memory will be performed. Blood samples will be taken to measure steroid hormones and chlordecone levels. Participants will be assessed at the inclusion visit where cognitive development scores will be recorded, and pubertal development onset will be monitored through growth rate analysis. The study relies on social security affiliation and informed consent from both the minor and the parents. The total participation covers the peripubertal period, with data collected on health, lifestyle, physical growth, hormone levels, and cognitive function to understand the impact of prenatal and postnatal exposure to chlordecone.

Age: 16Years - 22YearsAll Genders
1 location

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