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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating treatments for moderate acne in patients with darker skin types Fitzpatrick phototypes IV-VI, focusing on acne-related pigmentation that affects quality of life. This randomized controlled trial compares oral isotretinoin as a first-line treatment against the current standard of care involving oral antibiotics and topical creams. The study aims to assess which approach better improves pigmentation severity after six months. Participants will be assigned to one of two groups. One group receives oral isotretinoin starting at 0.5 mgkg daily for six months, with dose adjustments possible based on tolerance and effectiveness. The other group follows standard care, receiving topical tretinoin or adapalene along with doxycycline or lymecycline for three months, followed by evaluation at three and six months. Dose changes may occur according to clinical response. During the study, participants will attend monthly visits if receiving isotretinoin or visits at three and six months for the standard care group. Researchers will assess acne-related pigmentation severity, quality of life, and any adverse events. Participants must have a cell phone capable of taking high-definition selfies to assist in monitoring. The total study duration for each participant is six months, with ongoing safety and effectiveness checks.
Actively Recruiting
Healthy Volunteer
Peripheral neuropathies PN affect about 1% of people worldwide, especially older adults, causing problems with walking and chronic pain that reduce quality of life. In French Guiana, researchers think that unknown causes of PN may be linked to exposure to neurotoxic traditional plant remedies, arboviral infections like Zika, Chikungunya, and Dengue, and mercury contamination from illegal gold mining. This study aims to explore how these environmental factors relate to PN, including in people with diabetic neuropathy or chronic idiopathic axonal polyneuropathy. This is a prospective multicenter case-control study conducted at hospitals in Cayenne and Saint-Laurent du Maroni. Participants include patients with diagnosed diabetic peripheral neuropathy or chronic idiopathic axonal polyneuropathy, and a control group of hospital patients without neuropathy. At the initial visit, blood, urine, and hair samples will be collected to test for arbovirus antibodies and measure heavy metals like mercury and lead. Participants will also complete a questionnaire about their use of traditional plants. Participants will not have follow-up visits as part of the study. The main outcome measured is the comparison of exposure rates to these environmental factors between the case and control groups. Additional assessments include identifying genetic mutations and determining peripheral nerve disability at the time of enrollment. The study will help understand environmental risks that might explain unexplained cases of PN in this region.
Actively Recruiting
Researchers are conducting a global registry to monitor the long-term safety and effectiveness of Increlex therapy in children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency SPIGFD. This observational, non-interventional registry collects data from multiple countries including Austria, France, Germany, Italy, Poland, Spain, Sweden, the United Kingdom, and the USA. The main goal is to gather safety information during treatment and for at least five years after treatment ends. The registry includes participants who are starting, planning to start, or already receiving Increlex treatment as per local prescribing information. Increlex mecasermin is given as an injection with doses ranging from 40 to 120 mcgkg twice daily, prescribed by a physician. Data may be collected retrospectively for those already on treatment. The study tracks participants over long periods to observe treatment exposure, dose, and various health outcomes related to growth and development. Participants will be monitored for adverse events, including serious events and neoplasia, during treatment and up to five years afterward. Researchers will also assess changes in height, bone age, body mass index, pubertal stage, and quality of life. Biological markers like growth hormone and IGF-1 levels will be measured periodically. The registry collects comprehensive data on safety, effectiveness, and other health indicators to better understand outcomes in children and adolescents receiving Increlex therapy.
Actively Recruiting
Healthy Volunteer
Researchers are studying infant feeding practices among pregnant women in French Guiana, focusing on the impact of food insecurity during pregnancy. This observational study compares women who participated in the Nutri Pou Ti Moun project, which assessed food insecurity and maternal nutrition, with and without a health promotion intervention. The study aims to understand breastfeeding rates, infant feeding diversity, and child development outcomes in this unique socio-economic context. The study involves two groups one group of women who received a health promotion intervention including nutrition-related activities and fresh fruit and vegetable baskets, and a control group who did not receive this intervention. Both groups are part of the larger Nutri Pou Ti Moun project that collected extensive data on maternal diet, food security, and pregnancy outcomes. The intervention began in October 2023 and is ongoing. Participants provide data through medical and socio-demographic records, dietary information, and child development indicators such as growth and psychomotor skills. Researchers will assess exclusive breastfeeding prevalence at 3 months, dietary diversity in infants and mothers, and breastfeeding duration up to 12 months. The study also collects perspectives on breastfeeding practices from both mothers and healthcare professionals. Monitoring continues up to the childs first year to evaluate nutritional and developmental impacts.
Actively Recruiting
Researchers are evaluating the pharmacokinetics, efficacy, and safety of Hydroxycarbamide pediatric dispersible tablets given twice daily in children aged 9 months to 11 years with Sickle Cell Disease. This phase II, national, multicenter, non-randomized, open-label study aims to understand how the drug is processed in the body and its effects over a 12-month period. Participants will take Hydroxycarbamide twice daily for 12 months. They will attend clinic visits at screening, baseline, and at 1, 3, 6, 9, and 12 months during the study. The drug dosage is adjusted based on body weight and administered as half-strength dispersible tablets. Childrens involvement includes regular clinic visits for blood tests, monitoring of drug levels, and assessments of blood parameters and Sickle Cell Disease events. Acceptability of the treatment will be evaluated by both children and their parents using scales. Compliance will be tracked by pharmacy accountability of the medication units. Safety and adverse events will be closely monitored throughout the study duration.
Actively Recruiting
Metabolic Dysfunction Associated Liver Disease MASLD is a common condition linked to metabolic syndrome, with genetic factors like PNPLA3 variants thought to influence liver fat buildup and damage. This research aims to study these genetic variations among MASLD patients in the overseas territories population, primarily of African descent mixed with European and Indian heritage, to better understand their susceptibility to developing the more severe form, Metabolic Dysfunction Associated Steatohepatitis MASH. The study will analyze genetic samples from adult MASLD patients seen in hospital departments in Guadeloupe, French Guiana, and Runion Island. Researchers will examine PNPLA3 polymorphisms and assess clinical, imaging, and laboratory markers of MASLD severity at the time of inclusion. This observational study does not involve interventions but focuses on collecting biological samples and health data to explore genetic and clinical profiles. Participants will provide informed consent and undergo assessments including liver imaging and blood tests to evaluate disease stage and fibrosis. Researchers will track allele frequencies of PNPLA3 variants and the distribution of liver disease severity at baseline. The study will also monitor laboratory biomarkers linked to MASLD. The total participation timeline aligns with the inclusion visit, with data collection focused on initial evaluation and genetic analysis.