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NCT ID: NCT06026228 Not yet recruiting - Clinical trials for Chlordecone (Kepone) Toxicity

Effects of Probiotic Oral Intake on Plasma Chlordecone (Kepone) Concentrations in Individuals Environmentally Exposed to Pesticide in Martinique.

CHLOR-DETOX
Start date: April 2024
Phase: N/A
Study type: Interventional

The CHLOR-DETOX study is a single-centre, double-blind, prospective, interventional, controlled, exploratory pilot study on subjects environmentally exposed to the organochlorine pesticide (kepone or chlordecone, CLD) in the French Caribbean (Martinique island). To our best knowledge, it is the first clinical trial in such subjects evaluating the potential effect of oral probiotic intake (Limosilactobacillus reuteri) on the reduction of CLD plasma levels (chlordeconemia) and fecal excretion, thus concurring to the reduction of CLD toxicity in study subjects.

NCT ID: NCT05982132 Recruiting - Weight Loss Clinical Trials

Weight Changes Among Martinican Prisoners

NUTRI-LAJÔL
Start date: January 11, 2023
Phase:
Study type: Observational

Assessment of body weight change among prisoners in Martinique between admission in jail and 3 months later expressed as a percentage of admission weight. Intensity of physical activities, nutrition intakes and psychological state are also studied to describe associated factors to body weight change.

NCT ID: NCT05833529 Recruiting - Clinical trials for Cocaine Use Disorder

Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder

PICOC
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Cocaine is the 2nd most used illicit substance in Europe and its use implies numerous health complications as well as an annual social cost of 8.7 G d'€. Classical (picture, video, audio, imagery based or in vivo) cue exposure therapy for substance craving (CET), i.e. the irrepressible and non-voluntary desire to use the substance, failed to prove efficacious in treating substance use disorder. Virtual reality cue exposure therapy for substance craving (VRCET), is more immersive, realistic and controllable, and is suggested as being a more efficacious intervention in reducing craving as compared to classical CET. So far it's still not known, thus the secondary aim of the present randomized and clinical trial is to investigate, whether virtual reality cue exposure is more efficacious, as compared to classical cue exposure, in both eliciting and reducing cocaine craving in a clinical context of CET for cocaine craving. The main study aim to is to investigate whether a VRCET for cocaine craving based cognitivo-behavioral therapy (i.e. VRCET followed by memory focused cognitive therapy) is more efficacious than a behavioural therapy (i.e. classical exposure therapy to craving) in reducing cocaine craving. To do so, 54 voluntary residential patients in treatment for cocaine use disorder will be recruited from the Universitary Hospital Center of Martinique (CHUM, Martinique, France) and Saint-Esprit Hospital Center (CHSE, Martinique, France) and randomly allocated in either a 3 weeks individual experimental treatment (10 meetings of VRET for cocaine craving followed by 5 meetings of memory focused cognitive therapy) or a 3 weeks individual control treatment (15 meetings of pictures based exposure therapy for cocaine craving). Self-reported measures of retrospective (last 14 days) and in virtuo exposure cocaine craving will be collected at the beginning, after 10 days, after 15 days of treatment and 1 month post. Others secondary subjective, urinary and physiological cocaine use related measures will also be collected.

NCT ID: NCT05794646 Recruiting - Clinical trials for Substance Use Disorders

Community Intervention to Eliminate HCV Among People Who Use Drugs.

ICONE2
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is twofold with the evaluation of the feasibility and potential usefulness of an implementation strategy, and the efficiency of a community-based model of mass screening and immediate treatment of hepatitis C among People Who Use Drugs (PWUD) in three major cities in mainland France (Paris, Lyon and Marseille) and in one overseas city (Fort-de-France). The investigators will also describe the psychological and infectious comorbidities of drug users, determine the stages of the HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HIV (Human Immunodeficiency Virus) care cascade, and analyze the factors associated with HCV treatment failure. A qualitative study will investigate the acceptability of the RDS model. Participants will be screened in an out of bound research center and receive appropriate treatment for infectious, addictological and psychiatric troubles. They will receive coupons to give to their peers for them to participate in the study. Researchers will also compare the acceptability of referral to psychiatric care directly at the research site (intervention group) with that of referral directly to a city facility (control group).

NCT ID: NCT05773898 Not yet recruiting - Clinical trials for Suicide, Mental Disorders and Socio-health Profile of Suicided Persons

Contribution of Psychological Autopsy to the Understanding of Suicidal Behaviors in French Overseas Territories

AUTOPSOM
Start date: March 2023
Phase:
Study type: Observational

The mains objectives of our project are to coordinate the monitoring of suicides and to identify common or specific suicide risk factors in four overseas DROM-COM (French Polynesia, La Reunion, French Guiana and Martinique) by comparing to a site in mainland France (Amiens). A mixed approach (quantitative and qualitative) will be used, based on semi-directed interviews of the psychological autopsy type.

NCT ID: NCT05763225 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Validation of Patient E-tool to Measure Systemic Lupus Activity

OPTIMISE
Start date: February 9, 2023
Phase:
Study type: Observational

Validation of a self-questionnaire (SLEDAI-P/LUPIN) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.

NCT ID: NCT05532995 Recruiting - COVID-19 Clinical Trials

Responses to CPET in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network

Start date: February 1, 2023
Phase:
Study type: Observational

This retrospective collaborative study on persistent exercise intolerance after COVID-19 offers to perform a large descriptive analysis of CPET performed in real-life by pulmonologists, cardiologists and physiologists. Indeed, these practicians are regularly consulted for a persistent intolerance to exercise expressed by dyspnea and/or frank fatigability sometimes associated with muscular or thoracic pain. When these complaints persist beyond 3 months after the first symptoms, it is legitimate to perform a CPET: - Either to evaluate the functional impact of an identified organ deficiency (e.g. myocarditis, pulmonary fibrosis, etc.), - Or, in the absence of formal arguments for an identified organ deficiency, to observe possible abnormalities in physiological responses during an incremental exercise test, likely to explain the persistence of symptoms and intolerance to exercise. Indeed, the recent literature highlights the presence of non-specific ventilatory and cardio-circulatory abnormalities leading to various physio-pathological observations. Unfortunately, these reports now concern relatively small numbers of patients with very diverse clinical forms of Covid, comorbidities and habitus. In order to improve the understanding of persistent symptoms and in particular the diversity of physiological response presentations, the investigators propose to collect a very large amount of data through a web-based platform designed to collect the measurements made throughout the exercise test directly from the ergospirometer. The relevant data covers the period from January 2, 2020 to December 31, 2022 (i.e. 35 months), The retrospective data collection will be carried out from February 1, 2023 to December 31, 2023. The descriptive analysis will focus on the kinetics of all the variables measured and calculated on subgroups defined a priori on age, sex, comorbidities, acute covid severity, persistent symptoms post covid, regular habitual physical activity level, etc. according to the sample. The study is expected to collect data from around 1000 patients and to involve around 40 French-speaking investigators. However, this collaborative study is open on request to all centers wishing to participate, as the web platform has been developed for data collection in English.

NCT ID: NCT05501847 Recruiting - Heart Failure Clinical Trials

Heart Failure: Don't Forget the Role of Amyloidosis

TEAM-HF
Start date: July 27, 2023
Phase: N/A
Study type: Interventional

Heart failure is defined as the inability of the heart to provide sufficient output to meet the needs of the body. It can occur in the course of a myocardial infarction, angina pectoris, hypertension, etc. Its frequency increases with age. It is a major public health problem. Heart failure first appears during exercise, then at rest. Initially, the heart tries to adapt to the loss of its contraction force by accelerating its beats (increase in heart rate), then it increases in volume (thickening of the walls or dilation of the cardiac cavities). This extra workload for the heart eventually leads to heart failure. Cardiac amyloidosis is a possible cause of the disease in the West Indian population. Cardiac amyloidosis is a rare disease related to our own proteins that will accumulate and cluster together to form abnormal protein deposits that will eventually lead to heart failure. Cardiac amyloidosis particularly affects West Indians, due to the high frequency in this population of a genetic anomaly associated with the disease: the Valine 122 Isoleucine (Val122l) mutation of the transthyretin gene (protein transthyretin in which isoleucine is substituted for valine at position 122 (Ile 122)). Early detection of amyloidosis appears essential for the implementation of appropriate therapies and therefore for an improvement in patient survival. For this it seems important to better specify the frequency of cardiac amyloidosis in heart failure in the French West Indies.

NCT ID: NCT05493592 Not yet recruiting - Severe Obesity Clinical Trials

Pigeon Peas (Cajanus Cajan) : a Natural Anti-inflammatory Facilitating Weight Loss in Obese Patients Returning to Sport?

OBESICA
Start date: November 2022
Phase: N/A
Study type: Interventional

Adult obesity is due to an excess of body fat. This corresponds to all the fat in the body (or adipose tissue). It is opposed to the lean mass which corresponds to the weight of muscles, organs and viscera. It is defined from the body mass index (or BMI). BMI is calculated by dividing a person's weight by their height squared. According to these criteria, the prevalence of obesity has reached 17% of the entire adult population in mainland France (ESTENBAN 2015 study). The prevalence figures for obesity in the French overseas departments are higher than in mainland France. The latest epidemiological data available in Martinique and Guadeloupe (KANNARI 2015 study) show that approximately 60% of the adult population is overweight and 25% of the adult population is obese. Obesity is considered a chronic disease that increases the risk of cardiovascular and metabolic complications all the more when patients have a BMI ≥ 35 kg/m2, defining severe obesity. When BMI is equal to or exceeds 40 kg/m2, obesity is said to be "morbid" and the risk of cardiovascular complications increases by about 100% to 400% depending on the type of complications. The risk of mortality increases by 50 to 100% compared to the normal weight population. Obesity and inflammation Adipose tissue accumulates around the abdominal viscera after the fat storage capacity of the subcutaneous territories has been reached. The accumulation of visceral fat is accompanied by a low-grade inflammatory response that is responsible for the secretion of lipid derivatives and mediators toxic to the cardiovascular system and insulin sensitivity. The inflammatory response is characterized by the expression of numerous pro-inflammatory molecules synthesized by adipocytes and immunocompetent single-macrophage cells infiltrating the vascular stroma of adipose tissue. In addition, hyperglycemia and excess lipid intermediates cause the assembly of inflammasomes in the cytosol. Among them, the NLRP3 inflammasome involved in multiple human inflammatory pathologies. Inflammation opposes weight loss, hence the need to reduce the inflammatory response to facilitate weight loss in obese people. Pigeon pea, known for its anti-inflammatory properties, is a legume found in Creole gardens and traditionally eaten at Christmas. The OBESICA study aims at studying the interest of consuming pigeon pea associated with regular physical activity on the inflammatory state of the body and weight loss in obese patients.

NCT ID: NCT05491291 Not yet recruiting - Chronic Wounds Clinical Trials

Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique

VALRESCIC
Start date: November 2022
Phase: N/A
Study type: Interventional

Chronic wound of lower limb. In developed countries, the prevalence of chronic wounds is linked to the ageing of the population and the increase in chronic diseases such as diabetes, obesity and cardiovascular disease. Consequence: amputations of lower limb. The prevalence of chronic wounds is also variable across the globe. In addition, chronic wounds are associated with psychosocial problems such as poor quality of life, loss of professional activity and progressive de-socialization of patients. To improve the quality of care we need in french wound assessment tools validated scientifically like the RESVECH 2.0 scale, validated in the Spanish language.