Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api
{ "count": 4830, "next": "http://api.gregory-ms.com/trials/?format=api&page=2", "previous": null, "results": [ { "trial_id": 4348, "title": "ALS Phase II Study of NX210c", "summary": "<b>Conditions</b>: Amyotrophic Lateral Sclerosis\n<br /><b>Interventions</b>: Drug: NX210c; Drug: Placebo\n<br /><b>Sponsors</b>: Axoltis Pharma; ACT4ALS network\n<br /><b>Not yet recruiting</b>", "published_date": "2024-04-15T04:00:00Z", "discovery_date": "2024-04-26T04:25:56.792827Z", "link": "https://clinicaltrials.gov/study/NCT06365216?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06365216", "euct": null, "eudract": null }, "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": 4347, "title": "Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis; Secondary-Progressive Multiple Sclerosis; Mesenchymal Stem Cells\n<br /><b>Interventions</b>: Biological: Allogenic placenta derived mesenchymal stem cells\n<br /><b>Sponsors</b>: Tehran University of Medical Sciences\n<br /><b>Completed</b>", "published_date": "2024-04-11T04:00:00Z", "discovery_date": "2024-04-24T23:25:46.383681Z", "link": "https://clinicaltrials.gov/study/NCT06360861?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06360861", "euct": null, "eudract": null }, "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": 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": 4346, "title": "Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Behavioral: Physical activity condition; Behavioral: Waitlist condition\n<br /><b>Sponsors</b>: University of Illinois at Chicago\n<br /><b>Not yet recruiting</b>", "published_date": "2024-04-09T04:00:00Z", "discovery_date": "2024-04-23T04:25:34.249214Z", "link": "https://clinicaltrials.gov/study/NCT06355804?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06355804", "euct": null, "eudract": null }, "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": 4345, "title": "First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)", "summary": "<b>Conditions</b>: Amyotrophic Lateral Sclerosis (ALS); Mutation in the Superoxide Dismutase-1 (SOD1) Gene\n<br /><b>Interventions</b>: Drug: ALN-SOD; Other: Diluent; Drug: Placebo (PB)\n<br /><b>Sponsors</b>: Regeneron Pharmaceuticals\n<br /><b>Not yet recruiting</b>", "published_date": "2024-04-08T04:00:00Z", "discovery_date": "2024-04-19T04:25:59.732732Z", "link": "https://clinicaltrials.gov/study/NCT06351592?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06351592", "euct": null, "eudract": null }, "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": 4344, "title": "MS Balance: Comparison of the lab-based measurement of static and dynamic balance ability and corresponding clinical assessments in patients with multiple sclerosis – a pilot study", "summary": null, "published_date": "2024-03-18T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.391584Z", "link": "http://drks.de/search/en/trial/DRKS00033872", "source": "WHO XML import", "relevant": null, "identifiers": { "drks": "DRKS00033872" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13870131", "last_refreshed_on": "2024-04-08", "scientific_title": "MS Balance: Comparison of the lab-based measurement of static and dynamic balance ability and corresponding clinical assessments in patients with multiple sclerosis – a pilot study - MS Balance", "primary_sponsor": "Reha Rheinfelden", "retrospective_flag": "No", "date_registration": null, "source_register": "German Clinical Trials Register", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "None", "inclusion_gender": "All", "date_enrollement": "2024-04-03", "target_size": "20", "study_type": "observational", "study_design": "Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science", "phase": null, "countries": "Switzerland", "contact_firstname": "Frank", "contact_lastname": "Behrendt", "contact_address": "Salinenstrasse 98", "contact_email": "[email protected]", "contact_tel": "+41 (0)61 836 5387", "contact_affiliation": "Reha Rheinfelden", "inclusion_criteria": "Inclusion criteria: ? Diagnosed with MS\r<br>? Expanded Disability Status Scale (EDSS) 1-6.5\r<br>? Age = 18\r<br>? medically stable\r<br>? signed consent form\r<br>? able to walk 50 meters without walking aid", "exclusion_criteria": "Exclusion criteria: ? a relapse within the last 30 days\r<br>? a systemic cortison therapy within the last 30 days\r<br>? other neurological diseases", "condition": "<br>G35;Multiple sclerosis", "intervention": "Group 1: The study population includes patients diagnosed with multiple sclerosis. Two evaluation sessions per patient are planned. The first appointment is for conducting the 3D gait measurements while during the second one the clinical<br>balance related assessments will be executed. The first appointment will last a maximum of 60 minutes and the second a maximum of 90 minutes. The time interval between the first and second appointment for data collection will be between 1 and 7 days.", "primary_outcome": "The primary endpoint is the statistical relationship between static and dynamic equilibrium ability in individuals with multiple sclerosis captured through precise measurements in the 3D motion analysis laboratory.", "secondary_outcome": "The secondary endpoint is the statistical relationship between static/dynamic equilibrium ability in individuals with multiple sclerosis measured in a 3D motion analysis laboratory and various clinical assessments to measure balance ability.", "secondary_id": null, "source_support": "Reha Rheinfelden", "ethics_review_status": "Approved", "ethics_review_approval_date": "2023-11-22", "ethics_review_contact_name": "[email protected]", "ethics_review_contact_address": "Ethikkommission Nordwest- und Zentralschweiz, Basel", "ethics_review_contact_phone": "(+41)61-2681350", "ethics_review_contact_email": "[email protected]", "results_date_completed": null, "results_url_link": null }, { "trial_id": 4343, "title": "Effect of Balance, strength, core stability training on balance impairment in patients with mild Multiple Sclerosis", "summary": null, "published_date": "2024-03-18T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.363151Z", "link": "http://en.irct.ir/trial/75160", "source": "WHO XML import", "relevant": null, "identifiers": { "irct": "IRCT20240119060728N1" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13853764", "last_refreshed_on": "2024-04-08", "scientific_title": "Comparison of the effect of balance training and a combined of balance, strength, core stability training on static and dynamic balance (mobility) in patients with mild Multiple Sclerosis", "primary_sponsor": "Tehran University of Medical Sciences", "retrospective_flag": "Yes", "date_registration": null, "source_register": "IRCT", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "25 years", "inclusion_agemax": "40 years", "inclusion_gender": "Female", "date_enrollement": "2024-05-21", "target_size": "20", "study_type": "interventional", "study_design": "Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly assigned to one of the two groups A or B using the block randomization method with a block size of four and using a sealed envelope, Blinding description: All stages of the study for two control and intervention groups are done using a double blind design in separate sessions, namely each group does not know the type of exercises of the other group. The evaluation of patient s outcomes before and after the intervention are done by an expert assistant other than researchers themselves, who have no knowledge of the type of exercises of that person, which are done. Education of exercises is done by another specialist assistant. Data analysis is carried out by the researcher.", "phase": "3", "countries": "Iran (Islamic Republic of)", "contact_firstname": "Maryam Eghtesadi", "contact_lastname": null, "contact_address": "Sports Medicine Department., 1st floor., Mahdi Clinic Hospital., Imam Khomeini Hospital Complex., Down the Keshavarz Boulevard", "contact_email": "[email protected]", "contact_tel": "+98 21 6119 5270", "contact_affiliation": "Tehran University of Medical Sciences", "inclusion_criteria": "Inclusion criteria: Age between 25-40 years<br>Female gender<br>Suffering from Relapsing Remitting or Secondary Progressive Multiple Sclerosis based on McDonald Criteria and according to the neurologist's diagnosis<br>EDSS less than 4 (The person can walk more than 100 meters without help and independently)<br>The patient is being treated with common MS drugs<br>Complaints of balance disorder<br>Absence of other neurological diseases that lead to balance impairments<br>Not suffering from psychiatric diseases<br>Absence of orthopedic disorders and diseases that prevent exercises<br>Absence of cardiovascular and pulmonary diseases and disorders<br>Any other disorder or disease that prevents a person from doing exercises<br>Do not taking psychiatric drugs<br>No relapse in the last month<br>Not participating in a regular exercise program in the last 4 weeks<br>No treatment with corticosteroids (injection or oral) during the last 2 weeks", "exclusion_criteria": "Exclusion criteria: Participate in the sports program at the same time<br>Inability to complete exercises", "condition": "Balance impairment in patients with Multiple Sclerosis. <br>Multiple sclerosis", "intervention": "Intervention 1: Intervention group: The desired and intended intervention includes 8 weeks of home based exercises. These exercises in the intervention group include balance, strength, core stability exercises. The exercises include lower limb strength, core stability exercises 3 days a week and with 24 to 48 hours of recovery between strength, core stability training sessions and also performing balance exercises on empty days between Strength, core stability sessions (a total of 7 days per week of training, 3 days of strength, core stability training and 4 days of balance training). Intervention 2: Control group: Exercises in this group include eight weeks of home based exercise training, which includes performing balance exercises 7 days a week.", "primary_outcome": "Berg Balance Scale. Timepoint: Baseline (before the start of the intervention), eight weeks later (at the end of the intervention). Method of measurement: The sum of functional scales obtained by the patient in numbers.;10 meters walk test. Timepoint: Baseline (before the start of the intervention), eight weeks later (at the end of the intervention). Method of measurement: Walking time of the 6-meter distance with a stopwatch in seconds.;Timed Up and Go test. Timepoint: Baseline (before the start of the intervention), eight weeks later (at the end of the intervention). Method of measurement: Time of going back and forth at a distance of three meters with stopwatch in seconds.", "secondary_outcome": "Quality of life. Timepoint: Before starting the intervention at baseline and eight weeks later at the end of the intervention. Method of measurement: The total points obtained from the Short Form 36 Questionnaire.", "secondary_id": null, "source_support": "Tehran University of Medical Sciences", "ethics_review_status": "Approved", "ethics_review_approval_date": "2023-05-24", "ethics_review_contact_name": null, "ethics_review_contact_address": "Ethics Committee in Research of Sina Hospital, Tehran University of Medical Sciences", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 4342, "title": "Dynamic Neuromuscular Stabilization (DNS) Training", "summary": null, "published_date": "2024-03-19T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.334587Z", "link": "http://en.irct.ir/trial/75990", "source": "WHO XML import", "relevant": null, "identifiers": { "irct": "IRCT20240306061185N3" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13853895", "last_refreshed_on": "2024-04-08", "scientific_title": "Effects of Eight Weeks Dynamic Neuromuscular Stabilization (DNS) Training on Posture Stabilization and Walk Time in Patients with Multiple Sclerosis", "primary_sponsor": "The University of Shahid Beheshti", "retrospective_flag": "Yes", "date_registration": null, "source_register": "IRCT", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "40 years", "inclusion_agemax": "55 years", "inclusion_gender": "Male", "date_enrollement": "2024-03-24", "target_size": "40", "study_type": "interventional", "study_design": "Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple randomization method, unit: individually, randomization tool: to determine the grouping of people in the research by simple randomization method, first a list of people's names is prepared in Excel software. Then we select a random number for each person using the RAND function and finally group the people using the MOD ROW function.", "phase": "N/A", "countries": "Iran (Islamic Republic of)", "contact_firstname": "Hossein Rezaei", "contact_lastname": null, "contact_address": "No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala", "contact_email": "[email protected]", "contact_tel": "+98 24 3562 3177", "contact_affiliation": "The University of Shahid Beheshti", "inclusion_criteria": "Inclusion criteria: The type of MS in the participants of the present study is relapsing-remitting<br>The duration of the disease is 10 to 15 years<br>Age range from 40 to 55 years<br>The degree of disability is 4 to 5.5 on the EDSS scale", "exclusion_criteria": "Exclusion criteria:", "condition": "Multiple sclerosis.", "intervention": "Intervention 1: Intervention group: The DNS protocol will be performed on the intervention group in eight weeks, 3 times a week under the supervision of the examiner .Berg's 14-step test is used to measure balance. Berg's balance Scale or BBS is a clinical test to check static and dynamic balance, especially in neurological patients. This test takes about 15 to 20 minutes. The minimum score of each test is 0 and the maximum score is 4. Finally, the sum of all steps is considered as the total score. If the sum of acquired points of the patient is less than or equal to 20, the patient will need a wheelchair. If the sum of the patients points is greater than 20 and less than or equal to 40, the patient will need help in walking. Patients whose score is more than 40 can walk independently. The maximum score of the paper test is 56. Intervention 2: Control group: We ask the control group not to do any activities that affect the research process, including sports.", "primary_outcome": "Walking time in multiple sclerosis patients. Timepoint: Before the intervention and eight weeks later. Method of measurement: Berg Balance Test (BBT) and 10-meter walk test.", "secondary_outcome": null, "secondary_id": null, "source_support": "The University of Shahid Beheshti", "ethics_review_status": "Approved", "ethics_review_approval_date": "2023-08-22", "ethics_review_contact_name": null, "ethics_review_contact_address": "Ethics Committee of Sport Sciences Research Institute", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 4341, "title": "Effect of Thread Embedding Acupuncture on Spasticity of M.S", "summary": null, "published_date": "2024-03-22T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.234378Z", "link": "http://en.irct.ir/trial/74172", "source": "WHO XML import", "relevant": null, "identifiers": { "irct": "IRCT20121228011912N8" }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "article_count": 176 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13853733", "last_refreshed_on": "2024-04-08", "scientific_title": "Comparison of the Effectiveness of True and Sham Thread Embedding Acupuncture on Spasticity in Multiple Sclerosis Patients", "primary_sponsor": "Mashhad University of Medical Sciences", "retrospective_flag": "Yes", "date_registration": null, "source_register": "IRCT", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 years", "inclusion_agemax": "no limit", "inclusion_gender": "Both", "date_enrollement": "2024-04-03", "target_size": "38", "study_type": "interventional", "study_design": "Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The control group in acupuncture studies is called sham. Embedding studies are limited and the use of sham is not common in them. In this study, the sham is designed in such a way that all the embedding steps are performed, but the thread is not placed in the body tissue, Randomization description: Using the online site www.sealedenvelope.com, random allocation is done in two groups A (intervention) and group B (control). Block Randomization will be done with block sizes of 4 and 6 for random allocation. The prepared blocks will be placed inside the envelope. One of the envelopes will be randomly selected according to the order of patients' arrival, and patients will be assigned to groups. Allocation concealment is done using sealed opaque envelopes. By one of the team members, random numbers will be prepared and placed inside the envelope. Th", "phase": "3", "countries": "Iran (Islamic Republic of);Iran (Islamic Republic of)", "contact_firstname": "Hamidreza Bahrami Taghanaki", "contact_lastname": null, "contact_address": "Traditional and Complementary Medicine Faculty, Shahid Kharazmi Complex, Mashhad University of Medical Science Campus, Azadi Square", "contact_email": "[email protected]", "contact_tel": "+98 51 3884 8931-6", "contact_affiliation": "Mashhad University of Medical Sciences", "inclusion_criteria": "Inclusion criteria: Definitive diagnosis of MS based on McDonald's 2017 criteria by a neurologist<br>EDSS<7<br>Moderate to severe spasticity reported by the patient as NRS score=4 with poor response to usual antispasmodics<br>Willingness to participate in the study and sign informed consent<br>Not taking anticoagulants<br>No history of any coagulopathy<br>No history of acupuncture in the last 6 months<br>No history of relapse phase in the last 2 months<br>No change in maintenance treatments during the last 2 months<br>No history of sensivity to cephalosporins<br>No history of sensivity to each components of the thread<br>No history of incurable chronic systemic diseases and cancers<br>Not being pregnant or breastfeeding and using a safe contraceptive method", "exclusion_criteria": "Exclusion criteria: Imbalance to continue cooperation with the study<br>Incidence of sensivity reaction to the embedded thread<br>Incidence of resistant bleeding requires medicinal intervention<br>Incidence of the relapse phase requires receiving a medicinal pulse", "condition": "Multiple sclerosis (M.S). <br>Multiple sclerosis", "intervention": "Intervention 1: Intervention group: True 2cm Polydioxanon Thread Embedding Acupuncture in 30 acupoints (GV14, GV20, CV4, CV14, BL18, BL20, BL23, SP6, SP9, ST36, KI3, GB20, GB34, LI11 , LR3, LI4, BL57) in one session after disinfection. Intervention 2: Control group: Sham group, Needling of 30 acupoints mentioned above without embedded thread in one session.", "primary_outcome": "Disability Status Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Expanded Disability Status Scale (EDSS).;Spasticity Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Numerical Rating Scale (NRS).;Quality of Walking Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Multiple Sclerosis Walking Scale-12 (MSWS-12).;Activities of Daily Living (ADL) Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Barthel Index.;Pain Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: McGill pain questionnaire.", "secondary_outcome": "Fatigue Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Modified Fatigue Impact Scale (MFIS) questionnaire.;Quality of Sleep score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI-P).;Urinary Symptoms Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Actionable Bladder Symptom Screening Tool (ABSST).;Depression Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.;Quality of Life Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: EuroQoL Quality of Life questionnaire.", "secondary_id": null, "source_support": "Mashhad University of Medical Sciences", "ethics_review_status": "Approved", "ethics_review_approval_date": "2024-09-03", "ethics_review_contact_name": null, "ethics_review_contact_address": "Ethics committee of Mashhad University of Medical Sciences", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 4340, "title": "ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients", "summary": "<b>Conditions</b>: Multiple Sclerosis, Relapsing-Remitting\n<br /><b>Interventions</b>: Drug: Ofatumumab\n<br /><b>Sponsors</b>: Novartis Pharmaceuticals\n<br /><b>Not yet recruiting</b>", "published_date": "2024-04-03T04:00:00Z", "discovery_date": "2024-04-15T17:50:52.178431Z", "link": "https://clinicaltrials.gov/study/NCT06345157?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06345157", "euct": null, "eudract": null }, "categories": [ { "category_id": 39, "category_description": "ofatumumab, Kesimpta", "category_name": "Ofatumumab", "category_slug": "ofatumumab", "category_terms": [ "ofatumumab", "kesimpta" ], "article_count": 45 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13879985", "last_refreshed_on": "2024-04-08", "scientific_title": "An ITAlian Observational, Multicenter, 12-month, Single-arm Study to Evaluate the Effectiveness and Safety of Treatment With Ofatumumab (Kesimpta®) in a pOpulation of RRMS Patients in a Real-world Setting - the ITAKOS Study", "primary_sponsor": "Novartis Pharmaceuticals", "retrospective_flag": "Yes", "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": "2024-04-30", "target_size": "300", "study_type": "Observational", "study_design": null, "phase": null, "countries": null, "contact_firstname": "", "contact_lastname": "Novartis Pharmaceuticals", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "+41613241111", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Male or female outpatients =18 years old.\r<br>\r<br> 2. Patients diagnosed with RRMS (McDonald criteria 2017).\r<br>\r<br> 3. Patients newly treated with ofatumumab, for whom the decision to start treatment with\r<br> the drug has already been taken independently from study inclusion, based on clinical\r<br> practice and according to the SmPC and to AIFA reimbursement criteria and who already\r<br> successfully qualified for treatment with ofatumumab (i.e., passed the screening\r<br> procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment).\r<br>\r<br> 4. Patient or a legal representative of the patient must provide written informed consent\r<br> before any study assessment is performed.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Patients outside the approved label of ofatumumab.\r<br>\r<br> 2. Pregnant and lactating women.\r<br>\r<br> 3. Patients with any clinical condition that may interfere with the subject's ability to\r<br> cooperate and comply with the study procedures based on investigator's judgement.\r<br>\r<br> 4. Patients cannot participate in this non-interventional study if they also participate\r<br> in an interventional trial.\r<br>\r<br> 5. Treatment with ofatumumab prior to inclusion in this study or after 7 days from\r<br> baseline visit.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting", "intervention": "Drug: Ofatumumab", "primary_outcome": "Annualized relapse rate (ARR)", "secondary_outcome": "Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test);Fatigue Severity Scale [FSS];Quality of life parameters assessed by EQ-5D-3L;Treatment satisfaction assessed by TSQM-9;Expanded Disability Status Scale (EDSS);Variation of NfL in plasma;Adverse Events (AEs);Discontinuation rates due to AE and/or other reasons", "secondary_id": "COMB157GIT02", "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": 4339, "title": "Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Other: Digital HealthTechnology\n<br /><b>Sponsors</b>: SYSNAV\n<br /><b>Not yet recruiting</b>", "published_date": "2024-04-04T04:00:00Z", "discovery_date": "2024-04-15T17:50:52.149197Z", "link": "https://clinicaltrials.gov/study/NCT06346704?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06346704", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13880104", "last_refreshed_on": "2024-04-08", "scientific_title": "Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis (NHS-MS-EGYPT)", "primary_sponsor": "SYSNAV", "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": "2024-04-25", "target_size": "100", "study_type": "Observational", "study_design": null, "phase": null, "countries": null, "contact_firstname": ";", "contact_lastname": "Ahmed Elnemr, MD;Ferial Toumi", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";+33 2 78 00 10 98", "contact_affiliation": "Air Force Specialized Hospital Cairo;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Male or female subject aged from 18 to 65 years old.\r<br>\r<br> 2. Signed informed consent and ability to comply with study and follow-up.\r<br>\r<br> 3. Diagnosed with MS base on 2017 McDonald criterion\r<br>\r<br> 4. EDSS = 5.5\r<br>\r<br> 5. No clinical or radiological relapse within the last 3 months\r<br>\r<br> 6. For patient under treatment, the molecule and its dose should be stable about 2 months\r<br> before inclusion\r<br>\r<br> 7. Subject willing and able to comply to all study procedures including the Syde® related\r<br> ones\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Patient with a cognitive or communicational disorder disturbing the understanding of\r<br> the tasks or data collection\r<br>\r<br> 2. Previous or current disorder with an impact on current ambulation or motor function\r<br>\r<br> 3. Patient who have had surgery or traumatic injury in upper or lower limb within the\r<br> last 6 months before the inclusion or patients who have had major surgery or trauma\r<br> within the last 6 months before the inclusion\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Digital HealthTechnology", "primary_outcome": "Longitudinal change of 95th centile of stride velocity", "secondary_outcome": "Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT", "secondary_id": "PR5030-66", "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 } ] }