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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying moderate acne in patients with darker skin types (Fitzpatrick phototypes IV-VI) to compare the effects of oral isotretinoin against the current standard treatment on acne-related pigmentation (ARP). ARP affects about 65% of these patients and impacts quality of life by causing discoloration. The study aims to see if isotretinoin, usually prescribed only after antibiotics fail, is better as a first-line treatment for ARP severity after six months. This is a Phase 3, multicenter, randomized controlled trial involving 420 subjects. Participants will receive either oral isotretinoin starting at 0.5 mg/kg daily (adjusted based on tolerance and response, with a total cumulative dose target of 120 to 150 mg/kg) or a topical cream (retinoic acid or adapalene) combined with oral antibiotics (doxycycline or lymecycline) for the first three months. After three months, the effectiveness will be checked; if acne improves, antibiotics stop but topical treatment continues. If acne remains moderate or severe, isotretinoin may be started. The study compares these approaches over six months. During the study, participants will be monitored for acne severity and pigmentation changes. They must have a cell phone capable of taking high-quality selfie pictures for monitoring. Safety tests include blood work for liver function and lipids. Women of childbearing potential will have pregnancy tests and require effective contraception. Researchers will assess the severity of acne-related pigmentation at six months as the primary outcome. The study will last six months with close follow-up and clinical evaluations to track treatment response and safety.
Actively Recruiting
Healthy Volunteer
Peripheral neuropathies (PN) affect about 1% of people worldwide, especially older adults, causing walking difficulties and chronic pain that greatly reduce quality of life. However, 20-30% of PN cases have no clear cause. In French Guiana, researchers believe that local factors like the use of traditional plant remedies that may harm nerves, outbreaks of arboviral infections such as Zika, Chikungunya, and Dengue, and exposure to mercury from illegal gold mining might contribute to these unexplained cases or worsen existing nerve problems like diabetic neuropathy. This study is a prospective multicenter case-control design conducted in hospitals in Cayenne and Saint-Laurent du Maroni. Participants include patients diagnosed with diabetic peripheral neuropathy or chronic idiopathic axonal polyneuropathy (case group) and patients without peripheral neuropathy hospitalized or consulting at the same hospitals (control group). At the start, blood samples will be taken to test for arbovirus antibodies and measure heavy metals like mercury and lead. Urine and hair samples will also be collected to analyze heavy metal exposure. Participants will complete a questionnaire about their use of traditional plant remedies. There is no ongoing follow-up as part of this research. Participants will be evaluated at inclusion for exposure to arboviruses, heavy metals, and plant consumption to explore their association with peripheral neuropathies. Researchers will compare exposure rates between cases and controls. The study does not involve further monitoring or treatment interventions. Total participation involves a one-time visit for sample collection and questionnaire completion.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the diet diversity during pregnancy among women in French Guiana, comparing those who have participated in a health promotion intervention and those who have not. This observational study aims to better understand the prevalence of food insecurity among pregnant women admitted for childbirth, with special focus on women monitored by mother and child protection centers (PMI) who often face greater economic challenges. The study is part of the Nutri Pou Ti'moun 1 project addressing food and nutritional insecurity during pregnancy in the region. The intervention includes health promotion activities on nutrition, such as group workshops on nutrition, self-esteem, physical exercise, food budgeting, breastfeeding, and parenthood. Additionally, participants receive baskets of fresh fruits and vegetables. Women receiving this intervention are those attending PMI centers involved in the study, while the control group consists of pregnant women who did not benefit from the intervention. The study compares the prevalence of food insecurity between these two groups. Participants are involved through enrollment during pregnancy, with data collected at inclusion about their diet during pregnancy. The study also tracks which participants benefited from the intervention to avoid bias when assessing outcomes. Researchers measure food insecurity prevalence and diet descriptions, aiming to improve pregnancy monitoring and health education in the region. Participation includes monitoring through the French Guiana Perinatal Network and ongoing health promotion efforts.
Actively Recruiting
Researchers are monitoring the long-term safety and effectiveness of Increlex4, a treatment for children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD). This global registry study is observational and non-interventional, designed to collect safety data during treatment and for at least five years after treatment ends. The study includes participants who have already started Increlex4 therapy as well as those beginning treatment, across various countries including the USA and several European nations. Participants receive Increlex4, a mecasermin injection given twice daily at doses ranging from 40 to 120 mcg/kg or 0.04 to 0.12 mg/kg, as prescribed by their physician. The study does not assign treatments but records data from patients undergoing routine care. This registry captures real-world use of Increlex4 according to local approved guidelines for managing SPIGFD. Throughout the study, researchers collect information on serious adverse events, any adverse events, deaths, and withdrawals related to treatment. Data collection continues during the treatment period and up to 30 days after the last dose. Safety monitoring is the primary focus, with long-term follow-up planned for at least five years post-treatment to assess ongoing health outcomes in children and adolescents receiving Increlex4 therapy.
Actively Recruiting
Healthy Volunteer
Researchers are studying food insecurity during pregnancy in French Guiana and its effects on infant feeding practices. The study compares two groups of pregnant women who participated in the Nutri Pou Ti Moun project: those who received a health promotion intervention and those who did not. The research explores how breastfeeding and infant feeding relate to maternal nutrition, with the goal of understanding the impact of food insecurity on child health and development in this specific region. The health promotion intervention includes weekly workshops led by a health mediator focusing on diet, well-being, adapted physical activities, and breastfeeding promotion. Participants also receive baskets of fresh, local fruits and vegetables. The study involves an intervention group who received these activities and a control group who did not. Both groups were recruited from three public maternity hospitals in French Guiana. Women involved in the study will be monitored to assess breastfeeding rates and infant feeding patterns. Researchers will collect medical, biomedical, and socio-demographic data, as well as information on child growth and psychomotor development. The main outcome measured is the prevalence of exclusive breastfeeding at 3 months of age. The study also aims to compare infant feeding and child health outcomes between the intervention and control groups to better understand the effects of food insecurity during pregnancy.
Actively Recruiting
This research aims to assess the pharmacokinetics, effectiveness, and safety of Hydroxycarbamide Paediatric dispersible tablets taken twice daily in children aged 9 months to 11 years who have Sickle Cell Disease. It is a phase II, open-label, non-randomised, multicenter study conducted nationally. The study focuses on understanding how the medicine is absorbed and processed in the body, along with monitoring its impact and safety in this young population. Participants will receive Hydroxycarbamide dispersible tablets, each containing 50 mg of the drug, given at half-strength doses twice daily. The dosing is adjusted based on the child's body weight. The treatment period lasts 12 months. During this time, children will attend clinic visits at screening, baseline, and then at 1, 3, 6, 9, and 12 months to receive the medication and undergo evaluations. Throughout the study, researchers will perform various tests including blood work to measure drug levels such as area under the curve (AUC), time to maximum concentration (Tmax), and maximum plasma concentration (Cmax) at multiple points after starting treatment. They will also monitor safety and efficacy through clinical assessments and laboratory values. The total duration for each participant in the study is one year, with regular follow-up visits to ensure adherence and collect data on health outcomes.
Actively Recruiting
Healthy Volunteer
Researchers are investigating the frequency of major psychiatric disorders and substance abuse disorders among adults living in precarious, excluded, or homeless situations in and around Cayenne, French Guiana. This observational, descriptive, cross-sectional study aims to better understand the mental health needs of this vulnerable population, especially since mental health care resources are limited in the region. The study also explores differences in disorder types and healthcare usage compared to the general population of the area. The study involves observing adults over 18 years old who use support services for people in precarious or excluded situations or who are wandering in Cayenne and its surroundings. There are no experimental treatments or interventions; instead, researchers will assess the prevalence of psychiatric and substance abuse disorders through evaluations at a single center. Participants will be asked to provide information that allows researchers to measure the presence of psychiatric and substance abuse disorders at the start of the study. Researchers will also examine participants' use of healthcare and their perception of health. The information gathered will help guide improvements in human and structural care resources tailored to the specific needs of this underserved population.
Actively Recruiting
Metabolic dysfunction associated liver disease (MASLD) is a significant public health concern worldwide with a complex etiology attributed to behavioural, environmental, and genetic causes. The worldwide prevalence of MASLD is estimated to be 32.4% and constantly rising. Several studies suggest differences in the prevalence and severity of MASLD by race or ethnicity, which may be linked to differences in lifestyle, diet, metabolic comorbidity profile, and genetic background, among others. Race/ethnicity research is essential as it can provide valuable information regarding biological and genetic differences among people with similar cultural, dietary, and geographical backgrounds. There is ample epidemiological evidence on the role of genetic susceptibility in MASLD, mainly from studies showing the clustering of MASLD cases among families and observing differences in the prevalence and severity of MASLD among ethnicities. The Overseas territories population is predominantly of African descent due to slave trade of population from sub-Saharan Africa between the seventeenth and nineteenth centuries. They have also been a mixture from Europeans and Indians. Indian are descents from Latin America, initially present on the territories, and from Asia, after the abolition of slavery. Data about MASLD in Overseas territories are scarce. To our knowledge, one study reported the prevalence of MASLD in Caribbean and Hispanic populations resident in the United States compared with Hispanic residents in Latin America (Kallwitz 2015). In the later study, rates of MASLD were significantly lower in persons with Caribbean origin than those of Latin America heritage. Genetic susceptibility variations may partially explain the heterogeneity observed in the MASLD prevalence/incidence estimates from different geographical regions and the variability in disease severity among individuals. Genetic factors have been suggested as one of the underlying causes of racial/ethnic differences in susceptibility to MASLD. Among the building blocks of metabolic syndrome, type 2 diabetes and obesity have been significantly associated with an increased risk of MASH with more severe progression to cirrhosis or liver cancer. However, in overseas, the prevalence of type 2 diabetes (10%), high blood pressure (28%), or obesity (30%) are among the highest in France. PNPLA3 expression is implicated in intrahepatic lipid accumulation and is associated with lipotoxicity and the more severe phenotypes, including fibrosis and carcinogenesis. Therefore, in this study, PNPLA3 polymorphisms will be analysed to evaluate the profile of MASLD patients in overseas territories. A biological sample will be taken to analyse PNPLA3 polymorphisms in DROMSteatExpo study.