Institut National de la Santé Et de la Recherche Médicale, France — Biomedical Watch V2

Traitements6programmes

Essais3liés

Publications11liées

SourceDBlocale

Traitements

6

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
@HOME — ECOCAPTURE for the Assessment of Apathy Under Real-life ConditionsECOCAPTURE@HOME is a study which is currently being developed with the objective to capture the behavioral signature of apathy in everyday life context through remote monitoring of participants' behavior for about one month. Participants will not only be patients with apathy but also their spouse caregiver. Behavioral markers of apathy will be extracted from a combination of: 1/ objective physiological data from sensors on a bracelet worn by participants; 2/ subjective data filled by the caregiver through an application. Thus investigators will collect a pool of metrics and show they can measure three assumed behavioral markers of apathy (daytime activity, quality of sleep and emotional arousal), which in turn allow to predict caregiver's perception of the dyad's psychological state. The final goal is to lay the foundations for the development of a clinical tool for the remote follow-up of patient-caregiver couples.	Alzheimer	À vérifier	À vérifier	France	À vérifier
Lumbar PunctureBackground: Mature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effective. Primary Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide (RAdR) can be given safely to participants with relapsed or treatment refractory TCM. Other (Secondary) Objective: Measure the activity of this combination treatment. Eligibility: People age 18 and older who have a failed or relapsed after standard treatments for mature TCMs. Design: Participants will be screened for eligibility by performing the following tests or procedures: Physical exam Medical history Medicine review Blood and urine tests Symptom review Bone marrow examination Total Body imaging scans or x-rays Tumor biopsy Participants will have blood tests during treatment to make sure their blood cell counts are okay. Romidepsin is infused through an intravenous (IV) placed in one of the veins usually in the arm. Lenalidomide, dexamethasone, and CC-486 (5-azacitidine) are pills or capsules taken by mouth. Participants are asked to keep a diary of when they take their pills to make sure they are taking these medicines properly. Participants will have tumor imaging scans after every 2nd cycle (or 6 weeks) to check if the treatment is working. If the doctors are concerned the cancer has spread to the brain and/or spine, they will have scans of the area(s) and a sampling of the fluid around the brain/spine which is obtained through a small needle inserted into the lower part of the back for a short time to collect the fluid. This procedure is called a spinal tap or lumbar puncture. Participants who have tumor in their skin will have repeat exams of their skin and sometimes photographs taken of these areas to see if the treatment is working. Participants will also be asked to give blood, saliva, and sometimes have optional biopsies of their tumor where these tests are done for research purposes. After they have completed the protocol treatment (6 cycles), they will be asked to return to clinic 30 days after treatment has ended, then every other month (or 60 days) for the first 6 months, then every 3 months (90 days) for 2 years, and then every 6 months for years 2 to 4 after completing treatment. After 4.5 years, they will be seen once a year.	Cancer, Sclérose latérale amyotrophique	Non applicable	Traitement symptomatique	France	À vérifier
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor ImpairmentsDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé.	Sclérose latérale amyotrophique	À vérifier	Traitement symptomatique	France	À vérifier
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor ImpairmentsDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé.	Sclérose latérale amyotrophique	À vérifier	Traitement symptomatique	France	À vérifier
Lumbar PunctureBackground: Mature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effective. Primary Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide (RAdR) can be given safely to participants with relapsed or treatment refractory TCM. Other (Secondary) Objective: Measure the activity of this combination treatment. Eligibility: People age 18 and older who have a failed or relapsed after standard treatments for mature TCMs. Design: Participants will be screened for eligibility by performing the following tests or procedures: Physical exam Medical history Medicine review Blood and urine tests Symptom review Bone marrow examination Total Body imaging scans or x-rays Tumor biopsy Participants will have blood tests during treatment to make sure their blood cell counts are okay. Romidepsin is infused through an intravenous (IV) placed in one of the veins usually in the arm. Lenalidomide, dexamethasone, and CC-486 (5-azacitidine) are pills or capsules taken by mouth. Participants are asked to keep a diary of when they take their pills to make sure they are taking these medicines properly. Participants will have tumor imaging scans after every 2nd cycle (or 6 weeks) to check if the treatment is working. If the doctors are concerned the cancer has spread to the brain and/or spine, they will have scans of the area(s) and a sampling of the fluid around the brain/spine which is obtained through a small needle inserted into the lower part of the back for a short time to collect the fluid. This procedure is called a spinal tap or lumbar puncture. Participants who have tumor in their skin will have repeat exams of their skin and sometimes photographs taken of these areas to see if the treatment is working. Participants will also be asked to give blood, saliva, and sometimes have optional biopsies of their tumor where these tests are done for research purposes. After they have completed the protocol treatment (6 cycles), they will be asked to return to clinic 30 days after treatment has ended, then every other month (or 60 days) for the first 6 months, then every 3 months (90 days) for 2 years, and then every 6 months for years 2 to 4 after completing treatment. After 4.5 years, they will be seen once a year.	Sclérose latérale amyotrophique	Non applicable	Traitement symptomatique	France	À vérifier
@HOME — ECOCAPTURE for the Assessment of Apathy Under Real-life ConditionsECOCAPTURE@HOME is a study which is currently being developed with the objective to capture the behavioral signature of apathy in everyday life context through remote monitoring of participants' behavior for about one month. Participants will not only be patients with apathy but also their spouse caregiver. Behavioral markers of apathy will be extracted from a combination of: 1/ objective physiological data from sensors on a bracelet worn by participants; 2/ subjective data filled by the caregiver through an application. Thus investigators will collect a pool of metrics and show they can measure three assumed behavioral markers of apathy (daytime activity, quality of sleep and emotional arousal), which in turn allow to predict caregiver's perception of the dyad's psychological state. The final goal is to lay the foundations for the development of a clinical tool for the remote follow-up of patient-caregiver couples.	Alzheimer	À vérifier	À vérifier	France	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
@HOME — ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions	Alzheimer	À vérifier	NCT04865172	@HOME — ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions	COMPLETED
Lumbar Puncture	Sclérose latérale amyotrophique	Non applicable	NCT07213440	PremodiALS — Identification of Early Markers for ALS	RECRUITING
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments	Sclérose latérale amyotrophique	À vérifier	NCT04816227	Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments	RECRUITING

Publications

11

Molécule	Indication / population	Titre	Journal	Date
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		Pseudotumoral multiple sclerosis: unveiling its clinical and imaging characteristics.	Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		Neuromuscular, cardiovascular, and cognitive fatigue in motor learning: A systematic review.	Neuroscience and biobehavioral reviews
Lumbar Puncture		Implementation of a specialized inpatient HIV care model and in-hospital mortality in South Brazil: a before-after study.	Lancet regional health. Americas
Lumbar Puncture		CNS infection presenting as a periaqueductal "soap-bubble" lesion causing obstructive hydrocephalus with refractory CSF diversion.	Radiology case reports
Lumbar Puncture		Oral body temperature and cerebrospinal fluid pTau181 in older adults at increased risk of Alzheimer's disease.	Neurobiology of aging
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		In vivo mapping of striatal neurodegeneration in Huntington's disease with Soma and Neurite Density Imaging.	eLife
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		RFC1 Repeat Expansions in Chronic Idiopathic Axonal Polyneuropathy: Prevalence, Phenotype, and Diagnostic Implications.	Journal of the peripheral nervous system : JPNS
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		Loss of Neocortical Oligodendrocytes in Parkinson's Disease Patients-A Stereological Study.	Journal of neuroscience research
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		Brain structure abnormalities in neurodevelopmental synaptopathies.	NeuroImage. Clinical
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		Key principles for rehabilitation of critically ill patients with obesity.	Intensive care medicine
Mac2ALS — Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments		Impact of Sexuality in Patients With Motor Neuron Disease.	Muscle & nerve