Traitements43programmes
Essais20liés
Publications37liées
SourceDBlocale

Traitements

43
MoléculeIndication / populationPhaseObjectifPaysRésultat
AEROPROTECT — Intensity of Aerobic Training and Neuroprotection in Parkinson's DiseaseIn phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (\>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects. Parkinson Non applicable Traitement symptomatique + Neuroprotection France À vérifier
CETOMA — The Ketogenic Diet for Alzheimer's DiseaseThe ketogenic diet (KD) is a metabolic shift, which stimulates the liver oxidation of fatty acids to produce ketone bodies. These ketone bodies represent an alternative fuel source for the brain. The benefits of KD in epilepsia have been demonstrated for decades. This diet may also provide benefits in Alzheimer's disease (AD) where neuronal glucose utilization declines from the early stage. Besides, the KD could decrease neuroinflammation, oxidative stress and enhance mitochondrial biogenesis. In murin models of AD, KD or Medium Chain Triglycerides consumption were associated with lower neuroinflammation but also with a diminution of neuropathologic features of AD (amyloid and tau lesions in the brain). Moreover, behavioural effets and improvements in memory and motor function have been highlighted. In humans, recent studies suggest cognitive benefits (memory, executive function) in AD, including in the Mild Cognitive Impairment (MCI) stage. The feasibility and the adherence to the diet proved to be correct, in small samples, in particular in MCI individuals over a short follow-up period (3 to 6 months). This study aims at examining the feasibility of a KD followed-up for one year in participants with early AD (N=70). Change in brain metabolism will be assessed using PET scan after 12 months, comparing KD with control diet. The effects on cognition, quality of life and daily living functioning will be analysed. The safety, nutritional changes and adhesion to the diet will be monitored throughout the study. Alzheimer Non applicable Remyélinisation indirecte / réparation + Neuroprotection + Immunomodulation France À vérifier
Clorazepate DipotassiumThe purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room Migraine Phase 3 À vérifier France À vérifier
CouDuMyo — Estimation of Non-Reimbursable Costs for Patients With Duchenne Muscular Dystrophy in FranceDuchenne muscular dystrophy (DMD) is a chronic neuromuscular disorder affecting approximately 150 to 200 newborns annually, predominantly males, and is characterized by progressive muscle atrophy and weakness due to a complete absence of dystrophin. DMD presents a severe phenotype, with life expectancy typically extending into the third decade. Data on healthcare utilization and associated costs for DMD patients, particularly within the French healthcare context, remain limited. The EPARDYS study aims to examine the care pathways of these patients using data from the Banque Nationale des Données Maladies Rares (BNDMR) and the Système National des Données de Santé (SNDS), enabling a detailed characterization of patient demographics, healthcare utilization patterns, and associated costs. However, only direct costs eligible for reimbursement under the Affection Longue Durée (ALD 100%) scheme can be evaluated. Additional resources are consumed by DMD patients, particularly for medical care that falls outside the scope of reimbursement. Furthermore, the high level of dependency in these patients may lead to the need for home adaptations or other expenditures outside the healthcare domain but linked to the disease. Informal caregiving also plays a significant role. These additional family-incurred costs must be considered. The CouDuMyo study will aim to estimate all relevant cost components from a societal perspective, considering both minors and adults, whether they attend school or work. The medico-social aspect of care, along with the collection of data on aids and benefits received, will offer insights into the nature of the support available to families in France. The knowledge gained regarding non-reimbursable, disease-related costs according to patient characteristics will provide a comprehensive view of the financial burden borne by patients and their caregivers. This assessment is particularly relevant in the context of emerging therapies, which may reduce these associated costs. The main objective will be to describe the resource utilization associated with DMD care that is not eligible for reimbursement, including direct medical costs not covered, medico-social expenses, direct non-medical costs, and indirect costs. Myopathies À vérifier À vérifier France À vérifier
EVALHEP — Evaluation of the Ablation of Hepatic Lesions by ElectroporationIrreversible electroporation is a curative treatment for cancerous liver lesions, performed on deep-seated tumors that are not eligible for surgical resection or percutaneous thermal ablation. The EVALHEP project aims to develop criteria for evaluating the effectiveness of the treatment based on imaging, mathematical models, and numerical simulations to assist radiologists who perform these complex procedures. Cancer À vérifier À vérifier France À vérifier
Fine needle aspiration biopsy (FNAB)There is no scientific data on post-thermal ablation cytological aspects, but treated nodules that grow back significantly after a procedure justify a new cytology in order not to ignore a neoplastic process. The EU-TIRADS classification usually used to stratify the risk of cancer (and to justify a fine needle aspiration biopsy) of thyroid nodules is not validated for nodules treated by thermal ablation (TA) (post-RF nodules). However, these nodules often acquire ultrasound criteria of suspicion making it necessary to develop an ultrasound stratification of the risk of malignancy specific to nodules treated by TA. The objective of this work is to describe the ultrasound and cytological aspects of these treated nodules by performing a systematic assessment at 3 years after thermal ablation including systematic neck ultrasound and fine needle aspiration biopsy. Thus, an ultrasound and cytological atlas (Bethesda classification 2017) of nodules treated by thermal ablation will be constituted. Cancer Non applicable À vérifier France À vérifier
Haemostasis testsInvestigators identified a high risk of deep vein thrombosis and pulmonary embolism in patients presenting myotonic dystrophy type 1 treated in our hospital, 10 times higher than general population matched on age and sex. These venous thromboembolic events were frequently severe and lethal. Investigators suspect that this high risk of venous thromboembolism is due to coagulation abnormalities specific to myotonic dystrophy type 1. The purpose of this study is to determine: 1/ if there is a hypercoagulable state in myotonic dystrophy type 1 by testing patient's coagulation, and 2/ if genes encoding factors involved in coagulation have modified expression resulting in this hypercoagulable state. Understanding the pathophysiology will help preventing venous thromboembolism in these patients. It is the first study to describe this specific issue. Myopathies NA À vérifier France À vérifier
INFLAME-BANK — Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular ResearchINFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs). The primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis. The study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes. The expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases. Myopathies À vérifier Immunomodulation À vérifier
KetoprofenThe purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room Migraine Phase 3 À vérifier France À vérifier
Laser technology for intracerebral thermocoagulationLaser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring. The laser optical fiber is implanted into the lesion using stereotaxy. This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A. Carpentier et al, 2008, 2011). Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared). Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible. No therapeutic trial evaluating LITT in this indication has been performed to date. It is therefore necessary to study its feasibility and tolerance. Épilepsie Phase 1 À vérifier France À vérifier
MetoclopramideThe purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room Migraine Phase 3 À vérifier France À vérifier
Monocytes and megacaryocytes culture and RNA extractionInvestigators identified a high risk of deep vein thrombosis and pulmonary embolism in patients presenting myotonic dystrophy type 1 treated in our hospital, 10 times higher than general population matched on age and sex. These venous thromboembolic events were frequently severe and lethal. Investigators suspect that this high risk of venous thromboembolism is due to coagulation abnormalities specific to myotonic dystrophy type 1. The purpose of this study is to determine: 1/ if there is a hypercoagulable state in myotonic dystrophy type 1 by testing patient's coagulation, and 2/ if genes encoding factors involved in coagulation have modified expression resulting in this hypercoagulable state. Understanding the pathophysiology will help preventing venous thromboembolism in these patients. It is the first study to describe this specific issue. Myopathies NA À vérifier France À vérifier
PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714Multiple Sclerosis (MS) is an inflammatory disease where the immune cells invade the central nervous system and destroy an essential element of nerve conduction: the myelin. An interesting feature observed in some patients is a regenerative process, called remyelination, which leads to the production of new myelin. However, the extent of remyelination is very heterogeneous among patients, only a minority of patients show a really efficient repair process along the disease course. In this project, our aim is to explore in vivo the biological mechanisms leading to a successful remyelination in some patients and to a failure in remyelination in others. With this purpose in mind we propose to develop a translational research platform where patients with multiple sclerosis will be investigated in vivo for their potential of remyelination through a follow-up with recently developed imaging technologies using a synergistic combination of magnetic resonance imaging (MRI) and positron emission tomography (PET) to visualize and quantify myelin and neuroinflammation. In parallel blood immune cells from patients will be sampled and profiled to investigate how they could influence remyelination. This part will consist in i) grafting patients' lymphocytes in experimental rodent models of demyelination to characterize how they could promote or inhibit remyelination; ii) performing a functional and multi-omics analysis of peripheral macrophages and analyse relationships with remyelination profiles; iii) profiling T lymphocytes at the single cell level to associate specific subpopulation of the T cells with the remyelination potential assessed in patients with MRI/PET images and in grafted animals. SEP Non applicable Remyélinisation France À vérifier
Pregnancy and Medically Assisted Conception in Rare DiseasesRare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care. Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child. For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life. Lupus À vérifier Immunomodulation France À vérifier
Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO)The purpose of this study is to assess medical events during follow-up of adult patients having hypophosphatasia and consulting rheumatologists. Myopathies À vérifier À vérifier France À vérifier
REMYELIKIDS — Exploring Cortical Remyelination in Children With Multiple SclerosisMultiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo. SEP Non applicable Remyélinisation France À vérifier
RNA extractionInvestigators identified a high risk of deep vein thrombosis and pulmonary embolism in patients presenting myotonic dystrophy type 1 treated in our hospital, 10 times higher than general population matched on age and sex. These venous thromboembolic events were frequently severe and lethal. Investigators suspect that this high risk of venous thromboembolism is due to coagulation abnormalities specific to myotonic dystrophy type 1. The purpose of this study is to determine: 1/ if there is a hypercoagulable state in myotonic dystrophy type 1 by testing patient's coagulation, and 2/ if genes encoding factors involved in coagulation have modified expression resulting in this hypercoagulable state. Understanding the pathophysiology will help preventing venous thromboembolism in these patients. It is the first study to describe this specific issue. Myopathies NA À vérifier France À vérifier
SonoCloud-4 (SC4) deviceDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. Sclérose latérale amyotrophique Phase 1/2 Ralentissement de la progression France À vérifier
SPIN-VA — The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive PatientsCardiovascular risk factors such as obesity, diabetes, high blood pressure, high cholesterol, or smoking are associated with an increased risk of events such as myocardial infarction, stroke, or peripheral artery disease. Lifestyle and dietary measures, as well as pharmacological treatments, can help correct these risk factors. However, several studies have shown that even with optimal treatment, individuals at high risk still face a residual cardiovascular risk. This phenomenon is primarily attributed to the development of vascular lesions, meaning damage within the blood vessels. These lesions are largely due to inflammation, an activated immune state that is more pronounced in overweight individuals and significantly contributes to vascular damage, potentially shortening the lifespan of those with cardiovascular disease. Although anti-inflammatory therapies have proven effective in reducing this risk, they may interfere with tissue repair and the immune system. For this reason, it is essential to identify strategies that promote the resolution of inflammation without compromising these vital processes. Specialized pro-resolving mediators (SPMs) are compounds derived from omega-3 and omega-6 polyunsaturated fatty acids, which are naturally found in various foods such as fish. These mediators help limit the infiltration of inflammatory cells and initiate the repair of damaged tissues. This type of dietary supplement is already available over the counter, but its health benefits have not been extensively studied. Experimental animal studies have shown that restoring inflammation resolution through SPMs can prevent-or even reverse-cardiovascular damage and inflammation by directly acting on vascular cells and modulating the immune system. However, human data on the role of SPMs and inflammation resolution in vascular disease remain very limited. The investigators hypothesize that in individuals at high cardiovascular risk (due to obesity and hypertension), increasing circulating levels of SPMs through oral supplementation (as a dietary supplement) would improve vascular function, metabolic profile, and inflammatory and immune cell responses. In doing so, this may help reduce the residual risk of cardiovascular disease. The objective of this research is to assess whether a supplement enriched with SPMs can facilitate the resolution of inflammation, which is essential for restoring vascular function and thereby supporting the body's natural tissue repair mechanisms. To address the research question, the study plans to include 60 individuals with obesity and hypertension, all presenting a high cardiovascular risk, recruited from healthcare facilities located in France. This research is publicly funded by the French National Research Agency (Agence Nationale de la Recherche) through the European research project RESPIN-VAR, co-funded by ERA4Health and the European Union. Hypertension Non applicable Immunomodulation France À vérifier
TIPI² — Multimodal Study of the Human Brain Epilepsy TissueThe TIPI2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy. The aim of the study will be to identify new pathophysiological pathways. For this purpose, the investigators will investigate with a multimodal approach blood and brain samples from patients undergoing a surgery for focal drug-resistant epilepsy. The adult patients will be enrolled either during the pre-surgical evaluation or right before the surgery. Épilepsie Non applicable À vérifier France À vérifier
Transdermal nicotineMedical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among Parkinsonian patients. However, controlled studies provided conflicting results. One of our patients showed a substantial decrease of his parkinsonian symptoms under transdermal nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent safety, especially on cardiovascular level. Otherwise, the investigators performed an open pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a controlled study. In this study, all patients received daily doses during several months until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving their motor scores. The investigators now propose a phase II, controlled, single blind and randomised efficacy study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group without additional therapy) The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5 mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11 weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose "plateau phase", treatment will be progressively decreased by 15 mg weekly steps, over a de 6-week period followed by a five-week wash out phase. Taking into account results from the pilot study, a long-term high doses treatment, seems to be liable to improve patients who deeply suffer from their disease. This is why the investigators now propose this monocentric institutional project. Parkinson Phase 2 Neuroprotection + Traitement symptomatique France À vérifier
TRANSIMMUNOM — Phenomics in Autoimmune and Inflammatory DiseasesThe family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases. Myopathies À vérifier Immunomodulation France À vérifier
ultrasonography with or not sphincterotomyThe primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP). Cancer NA À vérifier France À vérifier
Usual procedureThe primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP). Cancer NA À vérifier France À vérifier
Laser technology for intracerebral thermocoagulationLaser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring. The laser optical fiber is implanted into the lesion using stereotaxy. This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A. Carpentier et al, 2008, 2011). Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared). Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible. No therapeutic trial evaluating LITT in this indication has been performed to date. It is therefore necessary to study its feasibility and tolerance. Épilepsie Phase 1 À vérifier France À vérifier
Pregnancy and Medically Assisted Conception in Rare DiseasesRare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care. Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child. For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life. Lupus À vérifier Immunomodulation France À vérifier
TRANSIMMUNOM — Phenomics in Autoimmune and Inflammatory DiseasesThe family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases. Myopathies À vérifier Immunomodulation France À vérifier
Haemostasis testsInvestigators identified a high risk of deep vein thrombosis and pulmonary embolism in patients presenting myotonic dystrophy type 1 treated in our hospital, 10 times higher than general population matched on age and sex. These venous thromboembolic events were frequently severe and lethal. Investigators suspect that this high risk of venous thromboembolism is due to coagulation abnormalities specific to myotonic dystrophy type 1. The purpose of this study is to determine: 1/ if there is a hypercoagulable state in myotonic dystrophy type 1 by testing patient's coagulation, and 2/ if genes encoding factors involved in coagulation have modified expression resulting in this hypercoagulable state. Understanding the pathophysiology will help preventing venous thromboembolism in these patients. It is the first study to describe this specific issue. Myopathies NA À vérifier France À vérifier
ultrasonography with or not sphincterotomyThe primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP). Cancer NA À vérifier France À vérifier
REMYELIKIDS — Exploring Cortical Remyelination in Children With Multiple SclerosisMultiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo. SEP Non applicable Remyélinisation France À vérifier
AEROPROTECT — Intensity of Aerobic Training and Neuroprotection in Parkinson's DiseaseIn phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (\>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects. Parkinson Non applicable Traitement symptomatique + Neuroprotection France À vérifier
Clorazepate DipotassiumThe purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room Migraine Phase 3 À vérifier France À vérifier
Fine needle aspiration biopsy (FNAB)There is no scientific data on post-thermal ablation cytological aspects, but treated nodules that grow back significantly after a procedure justify a new cytology in order not to ignore a neoplastic process. The EU-TIRADS classification usually used to stratify the risk of cancer (and to justify a fine needle aspiration biopsy) of thyroid nodules is not validated for nodules treated by thermal ablation (TA) (post-RF nodules). However, these nodules often acquire ultrasound criteria of suspicion making it necessary to develop an ultrasound stratification of the risk of malignancy specific to nodules treated by TA. The objective of this work is to describe the ultrasound and cytological aspects of these treated nodules by performing a systematic assessment at 3 years after thermal ablation including systematic neck ultrasound and fine needle aspiration biopsy. Thus, an ultrasound and cytological atlas (Bethesda classification 2017) of nodules treated by thermal ablation will be constituted. Cancer Non applicable À vérifier France À vérifier
INFLAME-BANK — Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular ResearchINFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs). The primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis. The study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes. The expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases. Myopathies À vérifier Immunomodulation À vérifier
SonoCloud-4 (SC4) deviceDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. Sclérose latérale amyotrophique Phase 1/2 Ralentissement de la progression France À vérifier
TIPI² — Multimodal Study of the Human Brain Epilepsy TissueThe TIPI2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy. The aim of the study will be to identify new pathophysiological pathways. For this purpose, the investigators will investigate with a multimodal approach blood and brain samples from patients undergoing a surgery for focal drug-resistant epilepsy. The adult patients will be enrolled either during the pre-surgical evaluation or right before the surgery. Épilepsie Non applicable À vérifier France À vérifier
Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO)The purpose of this study is to assess medical events during follow-up of adult patients having hypophosphatasia and consulting rheumatologists. Myopathies À vérifier À vérifier France À vérifier
CouDuMyo — Estimation of Non-Reimbursable Costs for Patients With Duchenne Muscular Dystrophy in FranceDuchenne muscular dystrophy (DMD) is a chronic neuromuscular disorder affecting approximately 150 to 200 newborns annually, predominantly males, and is characterized by progressive muscle atrophy and weakness due to a complete absence of dystrophin. DMD presents a severe phenotype, with life expectancy typically extending into the third decade. Data on healthcare utilization and associated costs for DMD patients, particularly within the French healthcare context, remain limited. The EPARDYS study aims to examine the care pathways of these patients using data from the Banque Nationale des Données Maladies Rares (BNDMR) and the Système National des Données de Santé (SNDS), enabling a detailed characterization of patient demographics, healthcare utilization patterns, and associated costs. However, only direct costs eligible for reimbursement under the Affection Longue Durée (ALD 100%) scheme can be evaluated. Additional resources are consumed by DMD patients, particularly for medical care that falls outside the scope of reimbursement. Furthermore, the high level of dependency in these patients may lead to the need for home adaptations or other expenditures outside the healthcare domain but linked to the disease. Informal caregiving also plays a significant role. These additional family-incurred costs must be considered. The CouDuMyo study will aim to estimate all relevant cost components from a societal perspective, considering both minors and adults, whether they attend school or work. The medico-social aspect of care, along with the collection of data on aids and benefits received, will offer insights into the nature of the support available to families in France. The knowledge gained regarding non-reimbursable, disease-related costs according to patient characteristics will provide a comprehensive view of the financial burden borne by patients and their caregivers. This assessment is particularly relevant in the context of emerging therapies, which may reduce these associated costs. The main objective will be to describe the resource utilization associated with DMD care that is not eligible for reimbursement, including direct medical costs not covered, medico-social expenses, direct non-medical costs, and indirect costs. Myopathies À vérifier À vérifier France À vérifier
PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714Multiple Sclerosis (MS) is an inflammatory disease where the immune cells invade the central nervous system and destroy an essential element of nerve conduction: the myelin. An interesting feature observed in some patients is a regenerative process, called remyelination, which leads to the production of new myelin. However, the extent of remyelination is very heterogeneous among patients, only a minority of patients show a really efficient repair process along the disease course. In this project, our aim is to explore in vivo the biological mechanisms leading to a successful remyelination in some patients and to a failure in remyelination in others. With this purpose in mind we propose to develop a translational research platform where patients with multiple sclerosis will be investigated in vivo for their potential of remyelination through a follow-up with recently developed imaging technologies using a synergistic combination of magnetic resonance imaging (MRI) and positron emission tomography (PET) to visualize and quantify myelin and neuroinflammation. In parallel blood immune cells from patients will be sampled and profiled to investigate how they could influence remyelination. This part will consist in i) grafting patients' lymphocytes in experimental rodent models of demyelination to characterize how they could promote or inhibit remyelination; ii) performing a functional and multi-omics analysis of peripheral macrophages and analyse relationships with remyelination profiles; iii) profiling T lymphocytes at the single cell level to associate specific subpopulation of the T cells with the remyelination potential assessed in patients with MRI/PET images and in grafted animals. SEP Non applicable Remyélinisation France À vérifier
Transdermal nicotineMedical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among Parkinsonian patients. However, controlled studies provided conflicting results. One of our patients showed a substantial decrease of his parkinsonian symptoms under transdermal nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent safety, especially on cardiovascular level. Otherwise, the investigators performed an open pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a controlled study. In this study, all patients received daily doses during several months until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving their motor scores. The investigators now propose a phase II, controlled, single blind and randomised efficacy study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group without additional therapy) The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5 mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11 weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose "plateau phase", treatment will be progressively decreased by 15 mg weekly steps, over a de 6-week period followed by a five-week wash out phase. Taking into account results from the pilot study, a long-term high doses treatment, seems to be liable to improve patients who deeply suffer from their disease. This is why the investigators now propose this monocentric institutional project. Parkinson Phase 2 Neuroprotection + Traitement symptomatique France À vérifier
EVALHEP — Evaluation of the Ablation of Hepatic Lesions by ElectroporationIrreversible electroporation is a curative treatment for cancerous liver lesions, performed on deep-seated tumors that are not eligible for surgical resection or percutaneous thermal ablation. The EVALHEP project aims to develop criteria for evaluating the effectiveness of the treatment based on imaging, mathematical models, and numerical simulations to assist radiologists who perform these complex procedures. Cancer À vérifier À vérifier France À vérifier
CETOMA — The Ketogenic Diet for Alzheimer's DiseaseThe ketogenic diet (KD) is a metabolic shift, which stimulates the liver oxidation of fatty acids to produce ketone bodies. These ketone bodies represent an alternative fuel source for the brain. The benefits of KD in epilepsia have been demonstrated for decades. This diet may also provide benefits in Alzheimer's disease (AD) where neuronal glucose utilization declines from the early stage. Besides, the KD could decrease neuroinflammation, oxidative stress and enhance mitochondrial biogenesis. In murin models of AD, KD or Medium Chain Triglycerides consumption were associated with lower neuroinflammation but also with a diminution of neuropathologic features of AD (amyloid and tau lesions in the brain). Moreover, behavioural effets and improvements in memory and motor function have been highlighted. In humans, recent studies suggest cognitive benefits (memory, executive function) in AD, including in the Mild Cognitive Impairment (MCI) stage. The feasibility and the adherence to the diet proved to be correct, in small samples, in particular in MCI individuals over a short follow-up period (3 to 6 months). This study aims at examining the feasibility of a KD followed-up for one year in participants with early AD (N=70). Change in brain metabolism will be assessed using PET scan after 12 months, comparing KD with control diet. The effects on cognition, quality of life and daily living functioning will be analysed. The safety, nutritional changes and adhesion to the diet will be monitored throughout the study. Alzheimer Non applicable Remyélinisation indirecte / réparation + Neuroprotection + Immunomodulation France À vérifier
SPIN-VA — The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive PatientsCardiovascular risk factors such as obesity, diabetes, high blood pressure, high cholesterol, or smoking are associated with an increased risk of events such as myocardial infarction, stroke, or peripheral artery disease. Lifestyle and dietary measures, as well as pharmacological treatments, can help correct these risk factors. However, several studies have shown that even with optimal treatment, individuals at high risk still face a residual cardiovascular risk. This phenomenon is primarily attributed to the development of vascular lesions, meaning damage within the blood vessels. These lesions are largely due to inflammation, an activated immune state that is more pronounced in overweight individuals and significantly contributes to vascular damage, potentially shortening the lifespan of those with cardiovascular disease. Although anti-inflammatory therapies have proven effective in reducing this risk, they may interfere with tissue repair and the immune system. For this reason, it is essential to identify strategies that promote the resolution of inflammation without compromising these vital processes. Specialized pro-resolving mediators (SPMs) are compounds derived from omega-3 and omega-6 polyunsaturated fatty acids, which are naturally found in various foods such as fish. These mediators help limit the infiltration of inflammatory cells and initiate the repair of damaged tissues. This type of dietary supplement is already available over the counter, but its health benefits have not been extensively studied. Experimental animal studies have shown that restoring inflammation resolution through SPMs can prevent-or even reverse-cardiovascular damage and inflammation by directly acting on vascular cells and modulating the immune system. However, human data on the role of SPMs and inflammation resolution in vascular disease remain very limited. The investigators hypothesize that in individuals at high cardiovascular risk (due to obesity and hypertension), increasing circulating levels of SPMs through oral supplementation (as a dietary supplement) would improve vascular function, metabolic profile, and inflammatory and immune cell responses. In doing so, this may help reduce the residual risk of cardiovascular disease. The objective of this research is to assess whether a supplement enriched with SPMs can facilitate the resolution of inflammation, which is essential for restoring vascular function and thereby supporting the body's natural tissue repair mechanisms. To address the research question, the study plans to include 60 individuals with obesity and hypertension, all presenting a high cardiovascular risk, recruited from healthcare facilities located in France. This research is publicly funded by the French National Research Agency (Agence Nationale de la Recherche) through the European research project RESPIN-VAR, co-funded by ERA4Health and the European Union. Hypertension Non applicable Immunomodulation France À vérifier

Essais cliniques

20
MoléculeIndication / populationPhaseNCTTitreStatut
SPIN-VA — The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients Hypertension Non applicable NCT07038252 SPIN-VA — The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients RECRUITING
CETOMA — The Ketogenic Diet for Alzheimer's Disease Alzheimer Non applicable NCT04701957 CETOMA — The Ketogenic Diet for Alzheimer's Disease TERMINATED
EVALHEP — Evaluation of the Ablation of Hepatic Lesions by Electroporation Cancer À vérifier NCT06289712 EVALHEP — Evaluation of the Ablation of Hepatic Lesions by Electroporation UNKNOWN
Transdermal nicotine Parkinson Phase 2 NCT00873392 NICOPARK2 — Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease COMPLETED
PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714 SEP Non applicable NCT05147532 SMARTinMS — Remyelination in Multiple Sclerosis: a PET-MR Longitudinal Study Investigating Individual Profiles of Myelin Repair and the Contribution of Neuroinflammation UNKNOWN
CouDuMyo — Estimation of Non-Reimbursable Costs for Patients With Duchenne Muscular Dystrophy in France Myopathies À vérifier NCT06861270 CouDuMyo — Estimation of Non-Reimbursable Costs for Patients With Duchenne Muscular Dystrophy in France COMPLETED
Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO) Myopathies À vérifier NCT05596539 Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO) RECRUITING
Obinutuzumab Lupus Phase 2 NCT07721363 OBLUMEN — Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial NOT_YET_RECRUITING
TIPI² — Multimodal Study of the Human Brain Epilepsy Tissue Épilepsie Non applicable NCT06022055 TIPI² — Multimodal Study of the Human Brain Epilepsy Tissue RECRUITING
SonoCloud-4 (SC4) device Sclérose latérale amyotrophique Phase 1/2 NCT07571486 Son-ALS — Therapeutic Approach of Repeated Transient Blood-brain Barrier Opening in Amyotrophic Lateral Sclerosis. RECRUITING
INFLAME-BANK — Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research Myopathies À vérifier NCT07737470 INFLAME-BANK — Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research NOT_YET_RECRUITING
Fine needle aspiration biopsy (FNAB) Cancer Non applicable NCT05726981 CYTOTHYRAF — Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules RECRUITING
Clorazepate Dipotassium Migraine Phase 3 NCT04726592 CLORMIG — Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room TERMINATED
AEROPROTECT — Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease Parkinson Non applicable NCT04046276 AEROPROTECT — Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease UNKNOWN
REMYELIKIDS — Exploring Cortical Remyelination in Children With Multiple Sclerosis SEP Non applicable NCT05258396 REMYELIKIDS — Exploring Cortical Remyelination in Children With Multiple Sclerosis RECRUITING
ultrasonography with or not sphincterotomy Cancer NA NCT00987428 EEPAB2 — Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis TERMINATED
Haemostasis tests Myopathies NA NCT03424460 DM1-VTE — Venous Thromboembolism in Myotonic Dystrophy Type 1 COMPLETED
TRANSIMMUNOM — Phenomics in Autoimmune and Inflammatory Diseases Myopathies À vérifier NCT02466217 TRANSIMMUNOM — Phenomics in Autoimmune and Inflammatory Diseases COMPLETED
Pregnancy and Medically Assisted Conception in Rare Diseases Lupus À vérifier NCT02450396 Pregnancy and Medically Assisted Conception in Rare Diseases WITHDRAWN
Laser technology for intracerebral thermocoagulation Épilepsie Phase 1 NCT05198882 Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy UNKNOWN

Publications

37
MoléculeIndication / populationTitreJournalDate
EVALHEP — Evaluation of the Ablation of Hepatic Lesions by Electroporation Irreversible electroporation versus radiofrequency ablation for malignant hepatic tumor: A prospective single-center double-arm trial. Journal of interventional medicine
EVALHEP — Evaluation of the Ablation of Hepatic Lesions by Electroporation Irreversible electroporation for liver cancer ablation: A meta analysis. European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology
EVALHEP — Evaluation of the Ablation of Hepatic Lesions by Electroporation A retrospective study of irreversible electroporation for tumors adjacent to perihepatic important structure. Frontiers in oncology
Metoclopramide Pharmaceutical policy and off-label prescribing in pregnancy: A population-based historical cohort study analyzing inequality in access to antiemetics within Australia's Pharmaceutical Benefits Scheme. Acta obstetricia et gynecologica Scandinavica
Metoclopramide Receptor-Targeted Antiemetic Strategies in Cats: A Systematic Review and Intervention-Specific Meta-Analysis. Veterinary medicine and science
Metoclopramide A scheme to tackle the dilemma from hepatoma cells under doxorubicin-resistant surroundings: a brightness or a silhouette. Artificial cells, nanomedicine, and biotechnology
Ketoprofen Membrane-mediated mechanisms of NSAID-induced cardiotoxicity independent of cyclooxygenase selectivity: Evidence from rat and zebrafish models. Toxicology and applied pharmacology
Ketoprofen Anti-inflammatory drugs disrupt granulosa cell homeostasis in vitro and impair bovine oocyte maturation and embryo development. Theriogenology
Clorazepate Dipotassium Benzodiazepines use in Morocco: A nation wide consumption database study between 2004 and 2017. Asian journal of psychiatry
Clorazepate Dipotassium Effect of Clomethiazole Vs. Clorazepate on Hepatic Fat and Serum Transaminase Activities in Alcohol-Associated Liver Disease: Results from a Randomized, Controlled Phase II Clinical Trial. Alcohol and alcoholism (Oxford, Oxfordshire)
SonoCloud-4 (SC4) device Impact of spin-orbit coupling on superconductivity in rhombohedral graphene. Nature materials
SonoCloud-4 (SC4) device Assessment of different treatment alternatives for patients with total maxillectomy. Journal of prosthodontics : official journal of the American College of Prosthodontists
SonoCloud-4 (SC4) device Mimicking Design Scaffolds Based on Nonwoven Biological Materials of Silk Cocoon for Soft Tissue Engineering at the Bone Interfacial Area: Structure, Morphology, and Performance Evaluation Based on In Vitro Testing, and Identification of Applied Biomaterials. ACS applied bio materials
RNA extraction Optimizing protocols for microRNA profiling of infant and toddler stool. RNA biology
RNA extraction Salivary RANKL and OPG gene expression quantification during intermaxillary elastic traction in orthodontic patients. MethodsX
RNA extraction A matrix-adapted RNA extraction strategy for targeted RT-qPCR analysis of periodontal ligament fibroblasts cultured on human amniotic membrane scaffolds. Regenerative therapy
Monocytes and megacaryocytes culture and RNA extraction Human neutrophils synthesize thrombomodulin that does not promote thrombin-dependent protein C activation. Blood
Pregnancy and Medically Assisted Conception in Rare Diseases Male circumcision. Pediatrics
Fine needle aspiration biopsy (FNAB) Unveiling the true impact of dominant thyroid nodules: are they really the Culprits? Surgery today
Fine needle aspiration biopsy (FNAB) Differences in ultrasonographic features and diagnostic value of biopsy between tuberculous lymphadenitis and reactive lymphadenopathy. Medicine
Fine needle aspiration biopsy (FNAB) Diagnostic Accuracy of Combined Fine-Needle Aspiration Biopsy and Ultrasonography for Malignancy in Bethesda III-IV Thyroid Nodules. Journal of clinical medicine
Usual procedure [Sterilization business continuity and recovery plan: How is it integrated into the quality management system?]. Annales pharmaceutiques francaises
ultrasonography with or not sphincterotomy Risk Factors for Peritonitis Associated With Endoscopic Ultrasound-guided Hepaticogastrostomy. DEN open
ultrasonography with or not sphincterotomy Advances in tuberculosis diagnostics and biomarkers, 2020-26: scientific evidence, recommendations, gaps, and developmental priorities. The Lancet. Microbe
INFLAME-BANK — Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research High Levels of (Un)Switched Memory B Cells Are Associated With Better Outcome in Patients With Advanced Atherosclerotic Disease. Journal of the American Heart Association
INFLAME-BANK — Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research Immunophenotype and Transcriptome Profile of Patients With Multiple Sclerosis Treated With Fingolimod: Setting Up a Model for Prediction of Response in a 2-Year Translational Study. Frontiers in immunology
RNA extraction Case series on Zika virus genome detection in cerebrospinal fluid samples from newborns at a Brazilian tertiary hospital. Revista do Instituto de Medicina Tropical de Sao Paulo
RNA extraction Celiac Disease: Cytokine Profile of Intraepithelial Gamma Delta T Cells in Disease Severity. Cells
Monocytes and megacaryocytes culture and RNA extraction Biologically active thrombomodulin is synthesized by adherent synovial fluid cells and is elevated in synovial fluid of patients with rheumatoid arthritis. Blood
Monocytes and megacaryocytes culture and RNA extraction Effects of hexadecylphosphocholine on thrombocytopoiesis. European journal of cancer (Oxford, England : 1990)
Haemostasis tests Establishment of reference values for prothrombin time, activated partial thromboplastin time and fibrinogen in adults in Burkina Faso. Annales de biologie clinique
Haemostasis tests Correlation Between Blood Coagulation Profile and Viscosity: Clinical Laboratory Observational Study. Medical sciences (Basel, Switzerland)
Pregnancy and Medically Assisted Conception in Rare Diseases Unable to walk or eat without assistance in pregnancy-Wilson's disease in a resource-limited and conflict-affected setting: a case report. Journal of medical case reports
AEROPROTECT — Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease Molecular mechanisms of exercise-induced neuroprotection against Parkinson's disease. Sports medicine and health science
AEROPROTECT — Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease Effects of physical exercise on neurofilament light chain in multiple sclerosis and other neurological disorders: A systematic review. Multiple sclerosis and related disorders
Pregnancy and Medically Assisted Conception in Rare Diseases Extensive Intracerebral Hemorrhage Involving Basal Ganglia and Frontal Lobe With Intraventricular and Subarachnoid Extension in a Triplet Pregnancy Following In Vitro Fertilization: A Case Report and Review. Clinical case reports
Pregnancy and Medically Assisted Conception in Rare Diseases Loss-of-Function Variants in CCDC189 Cause Human Oligoasthenoteratozoospermia by Disrupting Sperm Flagellar and Acrosomal Architecture. Andrology