Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=480
{ "count": 4830, "next": "http://api.gregory-ms.com/trials/?format=api&page=481", "previous": "http://api.gregory-ms.com/trials/?format=api&page=479", "results": [ { "trial_id": 38, "title": "Therapeutic Adherence of Multiple Sclerosis Patients", "summary": "Condition: Multiple SclerosisIntervention: Other: Study of the role of sociocognitive factorsSponsor : Lille Catholic UniversityNot yet recruiting ", "published_date": "2021-02-02T00:00:00Z", "discovery_date": "2021-04-08T11:57:29Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04837352", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04837352" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13875292", "last_refreshed_on": "2024-04-08", "scientific_title": "Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients", "primary_sponsor": "Lille Catholic University", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2022-01-18", "target_size": "153", "study_type": "Observational", "study_design": null, "phase": null, "countries": "France", "contact_firstname": ";", "contact_lastname": "Bruno Lenne;Marie-Paule Lebitasy, MD, PhD", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";03.20.22.52.69", "contact_affiliation": "Hôpital Saint Vincent de Paul, Lille;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Multiple sclerosis defined according to McDonald criteria;\r<br>\r<br> - Already undergone or beginning substantive treatment (self-managed, excluding\r<br> treatment administered in hospital)\r<br>\r<br> - Aged = 18 years;\r<br>\r<br> - Given the informed consent form.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Severe cognitive impairment (score below the 5th percentile);\r<br>\r<br> - Any associated neurological pathology or serious or chronic somatic disease (cancer);\r<br>\r<br> - Being under a legal protection measure.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Study of the role of sociocognitive factors", "primary_outcome": "Therapeutic adherence evaluated by a Likert scale", "secondary_outcome": "Perceived threat measured with a self-assessment form;Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP);Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS);Illness duration in days;Handicap will be evaluated by the Expanded Disability Status Scale (EDSS);Relapses number;Fatigue perceived through the FSS (Fatigue Severity Scale);Cognitive disorders through the SDMT (Symbol Digit Modalities Test);Anxiety-depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS);Personality traits measured by the Big Five Inventory-FR questionnaire (BFI-FR)", "secondary_id": "RC-P00105", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 39, "title": "Impact of Neuropsychological Disorders in Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Other: Three dimensional gait analysis with eyetrackingSponsor : Lille Catholic UniversityNot yet recruiting ", "published_date": "2021-07-04T00:00:00Z", "discovery_date": "2021-04-08T11:57:29Z", "link": "https://clinicaltrials.gov/show/NCT04837365", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04837365" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13154658", "last_refreshed_on": "2023-07-03", "scientific_title": "Impact of Neuropsychological Disorders on Visual Exploration, Walking Initiation and Walking in Multiple Sclerosis", "primary_sponsor": "Lille Catholic University", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2021-05-21", "target_size": "20", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).", "phase": "N/A", "countries": "France", "contact_firstname": ";", "contact_lastname": "Caroline Massot, MD;Amélie Lansiaux, MD, PhD", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";+33 3 20 22 52 69", "contact_affiliation": "GHICL;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Understanding and able to speak French\r<br>\r<br> - Carriers of MS with relapsing remitting form (RRMS-RR) with an EDSS <4\r<br>\r<br> - No significant motor, cerebellar or somesthesia disorders of the upper limbs or visual\r<br> disturbances (side to a visual EDSS <2)\r<br>\r<br> - Absence of corticosteroid intake in the last four weeks\r<br>\r<br> - Benefiting from health insurance coverage\r<br>\r<br> - Not showing any flare-ups or worsening of the disease in the last 6 weeks\r<br>\r<br> - No botulinum toxin injection for more than 4 months\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - People with previous neurological pathologies, head trauma with loss of consciousness,\r<br> psychiatric pathologies, serious general ailments, perceptual or dysarthric disorders\r<br> preventing verbal communication or reading,\r<br>\r<br> - Treatment with psychotropic drugs (except benzodiazepines and hypnotics).\r<br>\r<br> - Refusal to participate after clear and fair information about the study.\r<br>\r<br> - Adults under tutorship, curatorship or safeguard of justice\r<br>\r<br> - With orthopedic treatment influencing walking\r<br>\r<br> - Pregnant woman\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Three dimensional gait analysis with eyetracking", "primary_outcome": "Step length (in m);Walking speed (in m.s-1);Range of motion in the lower limbs in degrees;Cadence of walking (in cycles.min-1)", "secondary_outcome": "Ocular fixation time (measured in ms);Muscle contractions determined by the electromyogram (EMG) (mV);Displacements (in mm) during walking;Acceleration (in mm.s-2) during walking;Joint angles", "secondary_id": "RC-P00108", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 41, "title": "Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS", "summary": "Condition: Multiple SclerosisIntervention: Sponsor : University Hospital, Strasbourg, FranceRecruiting ", "published_date": "2021-02-26T00:00:00Z", "discovery_date": "2021-04-08T11:57:29Z", "link": "https://clinicaltrials.gov/show/NCT04838015", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04838015" }, "categories": [ { "category_id": 8, "category_description": "", "category_name": "Ocrelizumab", "category_slug": "ocrelizumab", "category_terms": [ "ocrelizumab", "ocrevus" ], "article_count": 226 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "10837273", "last_refreshed_on": "2021-04-19", "scientific_title": "Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS", "primary_sponsor": "University Hospital, Strasbourg, France", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2020-11-13", "target_size": "250", "study_type": "Observational", "study_design": null, "phase": null, "countries": "France", "contact_firstname": ";", "contact_lastname": "Nicolas COLLONGUES, MD;Nicolas COLLONGUES, MD", "contact_address": null, "contact_email": "[email protected];[email protected]", "contact_tel": "33 3 88 12 87 33;33 3 88 12 87 33", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion criteria:\r<br>\r<br> - Major subject (=18 years old)\r<br>\r<br> - Suffering from relapsing-remitting MS (RRMS)\r<br>\r<br> - Supported in a neurology department at Strasbourg or Nancy University Hospital between\r<br> 10/01/2018 and 11/31/2020.\r<br>\r<br> - Treated with ocrelizumab 600mg every 6 months during the period from 01/10/2018 to\r<br> 01/05/2020.\r<br>\r<br> - Have had an M0, M3 / M6 and M12 MRI after initiation of treatment.\r<br>\r<br> - Subject not having expressed his opposition, after information, to the reuse of his\r<br> data for the purposes of this research\r<br>\r<br> Exclusion criteria:\r<br>\r<br> - Subject having expressed opposition to participating in the study\r<br>\r<br> - Primary progressive multiple sclerosis (MS-PP), secondarily progressive (MS-SP)\r<br>\r<br> - Subject not meeting all the inclusion criteria\r<br>\r<br> - Impossibility of providing the subject with enlightened information (difficulties in\r<br> understanding the subject, etc.)\r<br>\r<br> - Subjects under safeguard of justice\r<br>\r<br> - Subject under guardianship or guardianship\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": null, "primary_outcome": "Retrospective study of the impact of ocrelizumab used in patients with multiple sclerosis", "secondary_outcome": null, "secondary_id": "8037", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 42, "title": "Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab", "summary": "Conditions: Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic ProcessesIntervention: Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody testSponsor : Dragonfly Research, LLCRecruiting ", "published_date": "2021-03-16T00:00:00Z", "discovery_date": "2021-04-08T11:57:29Z", "link": "https://clinicaltrials.gov/show/NCT04837651", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04837651" }, "categories": [ { "category_id": 7, "category_description": "", "category_name": "Natalizumab", "category_slug": "natalizumab", "category_terms": [ "natalizumab", "tysabri" ], "article_count": 298 }, { "category_id": 8, "category_description": "", "category_name": "Ocrelizumab", "category_slug": "ocrelizumab", "category_terms": [ "ocrelizumab", "ocrevus" ], "article_count": 226 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "11240373", "last_refreshed_on": "2021-08-10", "scientific_title": "A Real World, Prospective, Single-center, Observational Study Comparing Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab or Natalizumab", "primary_sponsor": "Dragonfly Research, LLC", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2021-03-02", "target_size": "48", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": "", "contact_lastname": "Joshua Katz, M.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Dragonfly Research, LLC", "inclusion_criteria": "<br> Inclusion Criteria\r<br>\r<br> - Age 18-55\r<br>\r<br> - Diagnosis of multiple sclerosis (as per the revised 2017 criteria)\r<br>\r<br> - EDSS score of 0-5.5 inclusive\r<br>\r<br> - Has initiated ocrelizumab or natalizumab at least 6 months prior to study enrollment\r<br>\r<br> - For women of childbearing potential: agreement to remain abstinent or to use a highly\r<br> effective (99% efficacy or greater) contraceptive method\r<br>\r<br> - Individual must be able to provide consent, read/write/comprehend English language or\r<br> must be able to provide a consistent translator\r<br>\r<br> Exclusion Criteria\r<br>\r<br> - Previous infection with COVID-19, confirmed by FDA approved testing\r<br>\r<br> - Cognitive impairment limiting the ability to consent or complete study procedures\r<br>\r<br> - Currently pregnant, planning to become pregnant during the study period, or currently\r<br> breastfeeding\r<br>\r<br> - Any prior use of immunosuppressive or chemotherapy treatment (including, but not\r<br> limited to, cladribine, alemtuzumab, mycophenolate mofetil, cyclophosphamide,\r<br> methotrexate, azathioprine)\r<br>\r<br> - Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12\r<br> months of first on-study infusion excluding standard ocrelizumab pre-treatment therapy\r<br>\r<br> - Use of systemic corticosteroid therapy within 12 weeks of screening (excluding\r<br> corticosteroid treatment given concurrently with ocrelizumab)\r<br>\r<br> - History of allergic reactions to vaccines\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Demyelinating Autoimmune Diseases, CNS;Autoimmune Diseases of the Nervous System;Nervous System Diseases;Demyelinating Diseases;Autoimmune Diseases;Immune System Diseases;Pathologic Processes", "intervention": "Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test;Device: T-Detect COVID T-cell blood test", "primary_outcome": "SARS-CoV-2 B-cell response;SARS-CoV-2 T-cell response", "secondary_outcome": null, "secondary_id": "VA26843", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 40, "title": "Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis", "summary": "Conditions: Multiple Sclerosis; Covid19Intervention: Sponsor : St. Barnabas Medical CenterRecruiting ", "published_date": "2021-04-07T16:00:00Z", "discovery_date": "2021-04-08T11:57:29Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04834401?cond=Multiple+Sclerosis&amp;sfpd_d=14&amp;sel_rss=new14", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT04834401" }, "categories": [], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 37, "title": "The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial", "summary": "Conditions: Multiple Sclerosis, Relapsing-Remitting; Pain, Chronic; Fatigue Syndrome, Chronic; KinesiophobiaInterventions: Behavioral: PMR: Progressive Muscle Relaxation; Behavioral: BRT:Benson Relaxation TechniqueSponsor : Hacettepe UniversityCompleted ", "published_date": "2021-05-04T00:00:00Z", "discovery_date": "2021-04-06T11:14:24Z", "link": "https://clinicaltrials.gov/show/NCT04833673", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04833673" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "10836988", "last_refreshed_on": "2021-04-19", "scientific_title": "The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial", "primary_sponsor": "Hacettepe University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2020-06-22", "target_size": "80", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).", "phase": "N/A", "countries": "Turkey", "contact_firstname": "", "contact_lastname": "gulsah kesik, MSc", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "research assisstant", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - over the age of 18\r<br>\r<br> - having relapsing-remitting MS type and not had an attack during the study\r<br>\r<br> - not receiving any other complementary and integrative therapy during the research,\r<br>\r<br> - with an Expanded Disability Status Scale score of 5.5 and below,\r<br>\r<br> - volunteer to participate in study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - having physical or mental health problems that can interfere with communication\r<br>\r<br> - having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem\r<br> such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis,\r<br> rheumatoid arthritis, deep anemia (hmg <8 mg / dl) or oncological diagnoses\r<br>\r<br> - not having undergone any surgical operation in the last 3 months\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting;Pain, Chronic;Fatigue Syndrome, Chronic;Kinesiophobia", "intervention": "Behavioral: PMR: Progressive Muscle Relaxation;Behavioral: BRT:Benson Relaxation Technique", "primary_outcome": "Fatigue", "secondary_outcome": "Chronic Pain;Kinesiophobia", "secondary_id": "333", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 36, "title": "Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants", "summary": "Condition: Relapsing Remitting Multiple SclerosisIntervention: Drug: NatalizumabSponsor : BiogenRecruiting ", "published_date": "2021-03-16T00:00:00Z", "discovery_date": "2021-04-05T11:38:24Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04832399", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04832399" }, "categories": [ { "category_id": 7, "category_description": "", "category_name": "Natalizumab", "category_slug": "natalizumab", "category_terms": [ "natalizumab", "tysabri" ], "article_count": 298 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13684825", "last_refreshed_on": "2024-02-12", "scientific_title": "Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)", "primary_sponsor": "Biogen", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2013-11-12", "target_size": "60", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Portugal", "contact_firstname": "", "contact_lastname": "Medical Director", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Biogen", "inclusion_criteria": "<br> Key Inclusion Criteria:\r<br>\r<br> - Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010\r<br> Criteria).\r<br>\r<br> - EDSS = 3.0.\r<br>\r<br> - Must fulfill Tysabri indication (relapse and MRI criteria).\r<br>\r<br> - Decision to start treatment with Natalizumab must precede enrollment.\r<br>\r<br> - Up to four natalizumab infusions.\r<br>\r<br> Key Exclusion Criteria:\r<br>\r<br> - Any prior treatment with Natalizumab.\r<br>\r<br> - Prior imunossupressive treatment (Mitoxantrone, Azathioprine, Methotrexate,\r<br> Cyclophosphamide, Mycophenolate, Cladribine, Rituximab).\r<br>\r<br> - Contraindications to treatment with Natalizumab.\r<br>\r<br> - History of Progressive Multifocal Leukoencephalopathy (PML) or other opportunistic\r<br> infections, or an increased risk for such infections.\r<br>\r<br> - Immunocompromised at the time of enrollment. Known active malignancies.\r<br>\r<br> - Inability to comply with study requirements.\r<br>\r<br> Note: Other protocol defined Inclusion/Exclusion criteria may apply.\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: Natalizumab", "primary_outcome": "Overall Disease-Free Status at Month 12;Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year;Annualized Relapse Rate at Month 12 in Comparison to the Previous Year", "secondary_outcome": "Overall Disease-Free Status at Months 24, 36 and 48;Clinical Disease-free Status Every 6 Months;Annualized Relapse Rate (ARR);Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained);MRI measures: T2, T1, T1 with Gadolinium (Gd);Cognitive Impairment Using Symbol Digit Modalities Test (SDMT);Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire;Quality of life (QoL) Assessed Using Fatigue Severity Scale;QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test;QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II);QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29)", "secondary_id": "PRT-TYS-12-10409", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 35, "title": "Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour", "summary": "Condition: Multiple SclerosisIntervention: Other: Exposure to methylprednisolone during pregnancySponsors : Jena University Hospital; Ruhr University of Bochum; Interdisciplinary Center of Clinical Research of the Medical Faculty Jena; Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRecruiting ", "published_date": "2021-02-18T00:00:00Z", "discovery_date": "2021-04-05T11:38:24Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04832269", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04832269" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13804356", "last_refreshed_on": "2024-03-18", "scientific_title": "Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain Development", "primary_sponsor": "Jena University Hospital", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "8 Years", "inclusion_agemax": "18 Years", "inclusion_gender": "All", "date_enrollement": "2020-10-19", "target_size": "80", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Germany", "contact_firstname": "; ;", "contact_lastname": "Matthias Schwab, Prof. Dr.;Michelle Dreiling, Dr.;Florian Rakers", "contact_address": null, "contact_email": ";[email protected];", "contact_tel": ";+493641 9 32 35 93;", "contact_affiliation": "University Hospital Jena;;University Hospital Jena", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - MS diagnosis was made based on the McDonald criteria valid at the time of diagnosis\r<br>\r<br> - Written consent by the legal guardians of the participating child following a detailed\r<br> oral and written education\r<br>\r<br> - Exposed group (n=40): Children and adolescents (aged 8 to 18 years) of mothers with\r<br> prenatal exposition to MP in the context of a MS relapse therapy\r<br>\r<br> - Non-exposed group (n=40): Children and adolescents of mothers suffering from MS\r<br> without MP therapy during pregnancy (aged 8 to 18 years) matched for age, gender and\r<br> social background\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Perinatal complications such as cerebral bleeding, neonatal intensive care with\r<br> ventilation, prenatal therapy with glucocorticoids except for an MS relapse\r<br>\r<br> - Maternal abuse of noxious agents during pregnancy\r<br>\r<br> - Long-term glucocorticoid medication (e.g. asthma)\r<br>\r<br> - Preterm births (before 36 weeks of pregnancy)\r<br>\r<br> - Severe disease making an examination impossible (e.g. mental retardation)\r<br>\r<br> - disease-modifying therapy during pregnancy\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Exposure to methylprednisolone during pregnancy", "primary_outcome": "General cognitive ability - Reynolds Intellectual Assessment Scales and Screening (RIAS)", "secondary_outcome": "Structural brain development - BrainAge score;Salivary cortisol decay curve;Salivary alpha-amylase;Heart rate variability;Spectral edge frequency in the EEG;External assessment sheet for attention deficit / hyperactivity disorder (FBB-ADHS, German Version);Child Behavior Checklist (CBCL/6-18R);Strengths and Difficulties Questionnaire (SDQ-Deu-S);Continuous Performance Test (CPT);Emotional excitability scale from Personality questionnaire for children between 9 and 14 years (PFK 9-14, German Version);Movement Assessment Battery for Children - Second Edition (M-ABC-2);Child anxiety test III (KAT-III, German version)", "secondary_id": "ZKSJ0130", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 34, "title": "Imaging Evaluation of Central Nervous Autoimmune Diseases", "summary": "Conditions: MS (Multiple Sclerosis); NMO Spectrum DisorderIntervention: Diagnostic Test: MRISponsor : Qilu Hospital of Shandong UniversityNot yet recruiting ", "published_date": "2021-11-03T00:00:00Z", "discovery_date": "2021-03-30T11:05:24Z", "link": "https://clinicaltrials.gov/show/NCT04822623", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04822623" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "10819689", "last_refreshed_on": "2021-04-12", "scientific_title": "Computer Aided Imaging Evaluation of Central Nervous System Autoimmune Diseases", "primary_sponsor": "Qilu Hospital of Shandong University", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2021-05-01", "target_size": "300", "study_type": "Observational", "study_design": null, "phase": null, "countries": null, "contact_firstname": "", "contact_lastname": "Xaoyu Han", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "18560081083", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. 18-65 years old;\r<br>\r<br> 2. Nmosd was diagnosed according to wingerchuk standard revised in 2015, MS was diagnosed\r<br> according to McDonald standard revised in 2017, and 100 normal people were diagnosed;\r<br>\r<br> 3. In the acute stage, within 1 month of the onset or stable stage, there was no GD\r<br> enhanced lesion on MRI, and EDSS score had no significant change within 6 months,\r<br> which was more than 1 month from the last attack;\r<br>\r<br> 4. MRI examination was complete: baseline, 6 months, 1 year, 2 years;\r<br>\r<br> 5. Sign informed consent.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. The course of disease was more than 30 years;\r<br>\r<br> 2. History of brain injury or spinal cord injury;\r<br>\r<br> 3. History of central nervous system infection or immunodeficiency syndrome;\r<br>\r<br> 4. HBV, HCV patients, syphilis, HIV-1, HIV-2 patients;\r<br>\r<br> 5. Suffering from mental illness;\r<br>\r<br> 6. Pregnant and lactating women or patients planning to conceive within one year;\r<br>\r<br> 7. Unable to cooperate to complete the follow-up due to geographical or other reasons;\r<br>\r<br> 8. Patients also participated in other randomized controlled trials.\r<br>", "exclusion_criteria": null, "condition": "MS (Multiple Sclerosis);NMO Spectrum Disorder", "intervention": "Diagnostic Test: MRI", "primary_outcome": "Results of MRI data analysis", "secondary_outcome": null, "secondary_id": "2020SDUCRCC019", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 33, "title": "Effects of Repeated Mesenchymal Stem Cells (MSC) in Patients With Progressive Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Biological: Mesenchymal Stem Cells (MSC)Sponsor : Hadassah Medical OrganizationCompleted ", "published_date": "2021-11-01T00:00:00Z", "discovery_date": "2021-03-30T11:05:24Z", "link": "https://clinicaltrials.gov/show/NCT04823000", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04823000" }, "categories": [ { "category_id": 12, "category_description": "Autologous Hematopoietic Stem Cell Transplantation (aHSCT) and other stem cell therapies", "category_name": "Stem Cells", "category_slug": "stem-cells", "category_terms": [ "stem cells", "Autologous hematopoietic stem cell", "ahsct" ], "article_count": 227 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "10819718", "last_refreshed_on": "2021-04-12", "scientific_title": "Long Term Clinical and Immunological Effects of Repeated Mesenchymal Stem Cells (MSC) Injections in Patients With Progressive Forms of Multiple Sclerosis (MS)", "primary_sponsor": "Hadassah Medical Organization", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2013-01-01", "target_size": "24", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 1/Phase 2", "countries": null, "contact_firstname": "", "contact_lastname": "Dimitrios Karussis, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Hadassah HMO", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Consenting patients fulfilling the Poser's criteria for definite MS\r<br>\r<br> 2. Age 18-70\r<br>\r<br> 3. Male and female\r<br>\r<br> 4. EDSS rate 5.5-7.5 (moderate to high disability)\r<br>\r<br> 5. Failure to two lines of the currently available registered immunomodulatory treatments\r<br> for MS. The lack of response to these treatments was determined by either an increase\r<br> in EDSS or the appearance of at least two relapses of MS during the year prior to\r<br> inclusion.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Patients who were treated with cytotoxic medications during the last three months\r<br> prior to the infusion.\r<br>\r<br> 2. Patients suffering from significant cardiac, renal or hepatic failure or any other\r<br> disease that may risk the patient or interfere with the ability to interpret the\r<br> results.\r<br>\r<br> 3. Patients with active infections.\r<br>\r<br> 4. Patients with cognitive decline or inability to understand and sign the informed\r<br> consent.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Biological: Mesenchymal Stem Cells (MSC)", "primary_outcome": "Appearance of adverse events;The changes in Expanded Disability Status Scale (EDSS) score 0-10 scale, higher scores show worsening of disability)", "secondary_outcome": "Changes in the percentage of CD4/CD25/FoxP3 triple positive stained cells (T regulatory cells), following MSC-treatment;Changes in the percentage of CD3+CD69+ cells (activated lymphocytes), following MSC-treatment;Changes in the percentage of CD11c+/CD86+/Lin- cells (dendritic cells and antigen-presenting macrophages), following MSC-treatment;Changes in the proliferation ability of mononuclear cells to PHA, following MSC-treatment", "secondary_id": "MSC-MS-001", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null } ] }