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Found 22 Actively Recruiting clinical trials
Actively Recruiting
Encephalitis and myelitis involve inflammation or infection of the brain or spinal cord. In Guadeloupe, where there is exposure to arboviruses and other infectious agents, many cases of these acute central nervous system infections do not have an identified cause. Researchers are evaluating the use of Next Generation Sequencing (NGS), a faster and more precise DNA and RNA sequencing method, to improve diagnosis and identify new or emerging pathogens in patients whose infections remain undiagnosed after standard testing. This observational study at the University Hospital of Guadeloupe includes patients with acute encephalitis or myelitis, defined by specific symptoms and diagnostic criteria. The study involves using advanced diagnostic methods including NGS on patients who have no identified infectious cause after initial assessments. The goal is to better understand the causes of these severe infections and gather detailed clinical, epidemiological, and diagnostic information. Participants will be assessed for neurotropic pathogens at the start and, if needed, three months later. Researchers will collect clinical, paraclinical, and epidemiological data to describe the disease characteristics and long-term outcomes. The study aims to enhance knowledge about these serious conditions and improve public health responses in the region.
Actively Recruiting
Chronic liver diseases impact over 800 million people worldwide and cause about 2 million deaths each year. Early detection and monitoring of liver disease progression remain a challenge due to the limited sensitivity and specificity of current serum markers and diagnostic tests. This research explores albumin post-translational modifications (PTM) as potential early biomarkers for liver disease progression, based on the idea that changes in albumin occur early in liver damage and may predict future disease. The study builds on preliminary findings showing distinct albumin profiles linked to different liver injuries and tests a novel Serum Enhanced Binding (SEB) method to detect these changes. The study plans to enroll 756 patients with chronic liver disease who have compensated fibrosis, recruiting from six university hospital centers over 1.5 years. Participants will not have extra study visits beyond their usual care appointments. Blood samples will be collected at inclusion and during follow-up visits at 1, 2, and 3 years, either by adding a tube to routine blood draws or reusing leftover samples. These samples will be analyzed centrally to measure albumin isoforms and ligand-binding capacity using advanced laboratory techniques. Participants will have data collected from their medical records during these visits, and blood tests will be used to evaluate albumin modifications. The main outcome is the ability of albumin PTM to predict liver damage progression over three years. Secondary goals include assessing different albumin isoforms and confirming characteristic profiles associated with specific liver injuries. This research aims to improve liver disease diagnosis and management by offering new insights into albumin's role in liver pathology.
Actively Recruiting
Chlordecone is a pesticide once used in the French West Indies that remains in the environment and continues to affect people through their food. This chemical has properties that can disrupt hormones, and animal studies suggest it may harm ovarian function and reduce ovarian reserve. However, no studies have yet explored how chlordecone exposure may impact female fertility in humans. This research aims to examine the relationship between chlordecone exposure and levels of anti-mullerian hormone (AMH), a marker of ovarian reserve, in women seeking help for infertility in Guadeloupe. The study will include women aged 18 to 39 who are consulting for couple infertility at the Caribbean Center for Reproductive Medicine of the University Hospital of Guadeloupe. Participants will undergo assessment of their AMH levels, which will be measured from tests conducted within one year prior to joining the study. The study does not involve specific treatments or interventions but focuses on evaluating the association between chlordecone levels and fertility markers. During the study, participants will provide information about their exposure and fertility status. Researchers will measure AMH levels and analyze how these relate to different amounts of chlordecone in the body. The main outcome is to understand if higher chlordecone exposure correlates with changes in AMH levels, which could affect fertility. Participation involves consent and consultation at the clinic, with monitoring based on existing fertility assessments.
Actively Recruiting
The progression of prostate cancer can vary widely depending on individual traits, disease aggressiveness at diagnosis, and ethno-geographic background. This research aims to identify clinical, genetic, and environmental factors that influence how the disease evolves, progresses, and leads to complications. Understanding these risk factors will help improve treatment decisions and tailor prevention and screening efforts, especially in high-risk populations with a high disease incidence. Participants will be followed in two groups based on their location and ethnic background: one group from Guadeloupe, primarily Afro-descendant, and another from Rennes, mainly Caucasian. They will receive standard care along with additional collections of blood, urine, and saliva samples to analyze genetic material, pollutants, microbiome, and other biological compounds. Structured questionnaires about lifestyle, medical history, occupation, and quality of life will be collected at diagnosis and regularly after treatment. Throughout the study, clinical data on the disease will be continuously gathered. Assessments will include anthropometric and blood pressure measurements, and questionnaires administered at diagnosis and follow-up visits. The main outcome is to study the link between various determinants and health events related to disease progression, measured at the start and at 1, 2, 5, and 10 years after inclusion and treatment start. This long-term follow-up will help better understand the factors influencing prostate cancer progression.
Actively Recruiting
Researchers are evaluating a personalized maintenance therapy for pemphigus, a life-threatening chronic autoimmune blistering disease affecting the skin and mucous membranes. This study focuses on comparing this personalized approach, which uses anti-desmoglein antibody levels as biomarkers, with the standard treatment involving rituximab combined with corticosteroids. The trial builds upon previous successful studies that supported rituximab's approval for pemphigus treatment by the FDA and EMA. Patients in the personalized maintenance group receive additional rituximab infusions based on their antibody levels and disease activity, aiming to prevent relapses and reduce the need for corticosteroids. The standard treatment consists of two doses of rituximab combined with oral corticosteroids, given after a clinical relapse. The study monitors antibody levels and disease activity over time to guide treatment decisions. Participants will undergo regular assessments, including clinical evaluations and antibody measurements, over a 7.5-year period to track the number of disease relapses per patient-year. The study also involves monitoring safety, treatment adherence, and the effectiveness of the personalized treatment strategy compared to the standard approach. Participation includes vaccination requirements and compliance with study protocols to ensure safety and reliable results.
Actively Recruiting
Researchers are studying gene variants of uncertain significance (VUS) found in genes linked to hereditary breast, ovarian, and other cancers. The goal is to better classify these VUS using data from a large French genetic database to improve genetic counseling and help guide clinical decisions, including preventive surgeries. The study originally focused on BRCA1 and BRCA2 genes but now includes multiple cancer-related genes identified through ongoing genetic testing in French families. Participants include index cases who carry specific VUS classified as uncertain or likely causal, along with their selected family members. Saliva samples are collected from these relatives to test for the presence of the variants. The study uses co-segregation analysis, which examines how the variant tracks with disease within families, applying a Bayesian model alongside other genetic and clinical data to estimate the likelihood that a variant causes cancer. Participants provide informed consent and saliva samples for genetic testing. Researchers compile data from multiple families to strengthen the classification of variants. The primary outcome is to perform co-segregation analysis over a period of up to 15 years. This long-term study aims to refine the clinical relevance of genetic variants to support personalized cancer risk assessment and counseling for affected families.
Actively Recruiting
Researchers are evaluating treatments for men aged 45 to 75 with favorable intermediate risk prostate cancer. This study compares focal High-Intensity Focused Ultrasound (F-HIFU) with radical prostatectomy (RP) to see which treatment is more cost-effective and provides better quality of life over 24 months. The trial is multicenter and randomized, initially with equal groups but later adjusted to a 2:1 ratio favoring F-HIFU, with follow-up extending to 48 months using health system data to monitor costs, mortality, and cancer control. Participants receive either F-HIFU using the Focal-One4 machine under local or general anesthesia, targeting specific prostate areas, or undergo radical prostatectomy performed by open, laparoscopic, or robot-assisted surgery under general anesthesia. Treatments follow standard procedures at each center, with randomization done up to 2 months before the procedure. During the study, participants will be monitored through medical records and health system data without extra visits. Researchers will assess the cost-effectiveness of treatments based on quality-adjusted life years (QALYs) at 24 months. Safety, cancer control, and mortality will also be tracked up to 48 months. The total participation time includes treatment and long-term follow-up using existing health data sources.
Actively Recruiting
Healthy Volunteer
Dat'AIDS Prevention is a cohort study conducted across more than 23 HIV sites in France, including overseas locations. It aims to describe all aspects of HIV prevention such as HIV screening, screening for sexually transmitted infections (STIs) and hepatitis, as well as the use of post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP). The study focuses on individuals seeking HIV prevention services to better understand prevention efforts in these settings. Participants include HIV-negative men and women aged 18 years and older attending for various services such as HIV screening, hepatitis screening, STI screening and treatment, exposure to blood, body fluids or sexual contact, and use of PEP or PrEP. Those who agree to participate provide signed consent to be included in the study. Throughout the study, researchers will track the number of patients enrolled for HIV prevention from the date of enrollment through to study completion, which lasts about one year on average. Participants will be monitored during this period to gather data on prevention practices and outcomes, supporting a comprehensive understanding of HIV prevention in France.
Actively Recruiting
Healthy Volunteer
Researchers are investigating how the blood levels of the S100B protein vary among healthy individuals from different ethnic backgrounds in Guadeloupe. S100B is a protein used to help manage minor to moderate traumatic brain injuries by potentially reducing the number of CT scans needed. Previous studies suggest that people with a Black skin phenotype may naturally have higher levels of S100B compared to those with Asian or Caucasian phenotypes, which could affect the accuracy of current testing thresholds, especially in populations like Guadeloupe where many people have a Black phenotype. The study will involve hospital staff from the University Hospital of Guadeloupe and the Hospital of Basse-Terre who meet specific eligibility criteria. After providing informed consent and completing a questionnaire about their ethnicity, age, sex, and weight, participants will have a blood sample taken. This sample will be analyzed at the University Hospital's biochemistry laboratory to measure their S100B protein levels. Participants will be involved in a one-time visit where they complete the questionnaire and provide a blood sample. The study aims to assess the natural variability of S100B levels according to skin phenotype and ethnicity. This includes comparing baseline S100B levels among different groups. Safety monitoring and long-term follow-up are not part of this study, which focuses on healthy subjects within an age range of 18 to 65 years.
Actively Recruiting
Researchers are studying the effects of chlordecone, a persistent organochlorine insecticide used in Guadeloupe and Martinique between 1973 and 1993, on child development during the peripubertal period. This long-term concern arises from the contamination of soil, water, and food, leading to exposure mainly through diet. The study builds on the Timoun mother-child cohort, tracking children born to women enrolled between 2004 and 2007, to explore possible health and developmental impacts linked to this environmental pollutant. Children born alive in the Timoun cohort will be followed up during their peripubertal years. Parents will complete questionnaires about their child's health and lifestyle, while researchers will perform physical measurements including height, weight, and cardiovascular assessments. Cognitive development will be evaluated using three specific tests, and blood samples will be taken to measure steroid hormone levels and chlordecone exposure. Participants will be assessed for cognitive abilities such as verbal comprehension, perceptual reasoning, and working memory at the study's start. The study involves collecting detailed health data, anthropometric measurements, and laboratory tests to monitor the impact of prenatal and ongoing exposure to chlordecone. The monitoring aims to address societal concerns about how environmental toxins affect sexual development and puberty timing in children and adolescents in Guadeloupe.
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