Clinical Trials Logo

Filter by:
NCT ID: NCT04334551 Recruiting - HIV Infections Clinical Trials

HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance

Start date: June 23, 2020
Phase: Phase 4
Study type: Interventional

This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed. The study will be performed only on two sites

NCT ID: NCT04260490 Recruiting - Multiple Myeloma Clinical Trials

Multiple Myeloma and Environmental Exposure to Pesticides in the French West Indies: A Population Based Case-control Study.

MYELODOM
Start date: November 19, 2019
Phase:
Study type: Observational

Multiple myeloma (MM) is a malignancy of plasma cells engaging in monoclonal immunoglobulin production. A strong presumption was established between exposure to pesticides and the risk of MM. The French West Indies departments of Guadeloupe and Martinique are characterized by a wide use of pesticides related to bananas plantation, particularly chlordecone which has been classified by IARC as possibly carcinogenic and has recognized hormonal properties (endocrine disruptor). The objective of this study is to measure the association between exposure to pesticide and other environmental factors in the occurrence of MM in Guadeloupe and Martinique and to estimate the proportion of cases of MM attributable to pesticide exposure. Genetic susceptibility markers and their links to environmental factors will be subsequently studies from blood samples collection.

NCT ID: NCT04211649 Recruiting - Mild Leptospirosis Clinical Trials

Comparing Two Antibiotic Therapy Periods (3 Versus 7 Days) in Patients With Mild Leptospirosis and Seen at the Hospital in 5 French Overseas Departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte)

LEPTO3
Start date: September 29, 2023
Phase: Phase 4
Study type: Interventional

Leptospirosis is a globally distributed neglected tropical disease affecting subtropical and tropical areas, such as the Caribbean and the Indian Ocean, with favorable climatic conditions for disease transmission. It shows a strong seasonality, with epidemic potential especially after heavy rainfall. A recent systematic review by Costa et al. (2015) places leptospirosis among the leading zoonotic causes of morbidity and mortality worldwide, with 1.03 million cases and 58,900 deaths each year. Leptospirosis is an important public health problem, particularly within economically vulnerable populations. It is also emerging as a health threat in new settings due to globalization and climate change. Disasters and extreme weather events are recognized to precipitate epidemics. Clinical manifestations are highly polymorphic, ranging from an anicteric, influenza-like form to severe forms with hepato-renal or pulmonary failures which are associated with high mortality. Antibiotic therapy should be prescribed early, as soon as leptospirosis is suspected and preferably within the first 5 days, before leptospira spread to the tissues. In the treatment of mild forms, usual antibiotics are oral amoxicillin or doxycycline for a standard treatment duration of 7 days. In hospitalized cases of leptospirosis, parenteral antibiotic therapy with ceftriaxone is often favored as first-line therapy. The most widely used antibiotics in the French Caribbean and Indian Ocean regions are amoxicillin, doxycyclin and third generation cephalosporins such as ceftriaxone. Research hypothesis: The effects of shorter antibiotic therapy periods for other infectious diseases have been explored by several authors. The efficacy of short ceftriaxone treatment has been highlighted for typhoid fever or meningococcal meningitis. In a retrospective series of 21 cases, the interest of short treatment periods (3-6 days) for mild and severe leptospirosis has also been described. A minimal 3-day therapy period would seem necessary in order to biologically confirm leptospirosis diagnosis and to rule out other community-acquired infections. Our study proposal is the conduct of a non-inferiority trial comparing a shortened antibiotic therapy period of 3 days with the standard treatment period of 7 days in patients with mild leptospirosis and seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte). Originality and innovative aspects: To our knowledge, the efficacy of a 3-day antibiotic therapy for mild leptospirosis, as compared to the standard 7 day period, has not yet been explored. In addition, the LEPTO3 study will be among the first clinical trials to focus on the endemic public health problem, which is leptospirosis, at a large geographical level (Caribbean and Indian Ocean regions) and to involve a high level of collaboration between medical and scientific teams of these territories.

NCT ID: NCT04174807 Recruiting - Gastroschisis Clinical Trials

Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

LaparoDAN
Start date: December 1, 2019
Phase:
Study type: Observational

Gastroschisis is a rare congenital malformation consisting in a right para-umbilical defect of the abdominal wall leading to an evisceration of the abdominal content. About 25% of the cases are associated with intestinal malformation, leading to an increase in peri-natal morbidity and mortality. No prospective study has been able to definitely describe predictive factors for complicated gastroschisis on prenatal ultrasound examinations. The aim of the current study is to prospectively look for US prenatal features predictive of complicated gastroschisis, on a national multicentric cohort. Patients will be included during the 22 weeks of amenorrhea (WA) ultrasound examination, and pre- and postnatal clinical data will be recorded up to the 6th months of the child. Data will then be analysed and compared in the groups of simple or complicated gastroschisis, in order to define pre-natal prognostic factors, to correlate them with specific prognosis, and to might better determine specific strategies for better care of these patients.

NCT ID: NCT04115007 Recruiting - Clinical trials for Oligometastatic Hormone Sensitive Prostate Cancer

Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients

Oligo-PRESTO
Start date: June 23, 2020
Phase: Phase 3
Study type: Interventional

INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study. PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.

NCT ID: NCT04076683 Completed - Sickle Cell Disease Clinical Trials

Algorithm for Apherisis Monitoring and Prescription Assistance in Sickle Cell Patients (ALGODREP)

ALGODREP
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

The main objective of this study is to prove the superiority of a procedure which calculates the volume of RBCs to transfuse and the time between apheresis based on this algorithm, compared to the current procedure. The primary endpoint would be the number of patients with individually achieved objectives in terms of % HbS before each apheresis (which reflects the effectiveness of the previous apheresis) over a period of 12 months. The secondary objectives would be to compare the volume differences of transfused RBCs in both groups over a period of 12 months, the occurrence of clinical events and the satisfaction of patients and physicians. The investigators hope that this study would improve the efficiency and the performance of apheresis in sickle cell patients. The investigators also hope to facilitate the organization of procedures with the flexibility that would allow the use of this algorithm.

NCT ID: NCT03981003 Recruiting - Multiple Sclerosis Clinical Trials

Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

NeurofilMS
Start date: May 22, 2019
Phase:
Study type: Observational

The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease. In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.

NCT ID: NCT03919357 Completed - Clinical trials for Developmental Disability

Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi

ValidBMTI
Start date: March 7, 2019
Phase:
Study type: Observational

The group of experts at HAS has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications International Classification of Diseases (CIM) CIM 11 and Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation. This orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned. The BMTi, a battery of third-generation tests (after the Rapid battery of evaluation of the cognitive functions (BREV) and then the Evaluation of cognitive functions and learning of the child (EDA)) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. . The research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.

NCT ID: NCT03900221 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

French Registry for Monitoring Pregnancies for Multiple Sclerosis

RESPONSE
Start date: August 12, 2019
Phase:
Study type: Observational [Patient Registry]

The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia. To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)

NCT ID: NCT03835130 Completed - Clinical trials for Pleuro-pulmonary Surgery

Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery

REC
Start date: January 25, 2019
Phase:
Study type: Observational

In postoperative pleuro-pulmonary surgery, the monitoring of the appearance of complications is guided, depending on the centres, by the systematic daily performance or, in the event of a call point, by chest x-ray at the patient's bed until the drains are ablative. This repeated performance of radiographs results in irradiation of patients but also of medical staff and a significant cost. In the thoracic study, ultrasound imaging is a fast, cost-effective, non-irradiating solution that can be performed at the patient's bedside. It could guide the performance of chest x-ray, limit their number, with increased clinical relevance.