Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=6
{ "count": 4874, "next": "http://api.gregory-ms.com/trials/?format=api&page=7", "previous": "http://api.gregory-ms.com/trials/?format=api&page=5", "results": [ { "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": "2024-05-17T00:00:00Z", "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": 180 } ], "export_date": "2024-05-17T00:00:00Z", "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": "2024-03-27T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.178431Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06345157", "source": "WHO XML import", "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": 47 } ], "export_date": "2024-05-17T00:00:00Z", "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": "2024-03-29T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.149197Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06346704", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06346704", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13961067", "last_refreshed_on": "2024-05-13", "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": "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": "Egypt", "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 }, { "trial_id": 4338, "title": "Effect of acupuncture on MS quality of life", "summary": null, "published_date": "2024-04-03T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.124629Z", "link": "http://en.irct.ir/trial/75872", "source": "WHO XML import", "relevant": null, "identifiers": { "irct": "IRCT20171007036614N5" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13853857", "last_refreshed_on": "2024-04-08", "scientific_title": "The effect of acupuncture on the quality of life of patients with multiple sclerosis (MS): randomized controlled clinical trial", "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": "18 years", "inclusion_agemax": "65 years", "inclusion_gender": "Both", "date_enrollement": "2024-05-21", "target_size": "80", "study_type": "interventional", "study_design": "Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized equally to intervention and control groups by simple individualized randomization method. For allocation of the participants, an Excel generated list of random numbers will be used. The allocation sequence will be concealed in sealed, opaque envelopes. After the initial evaluation and obtaining the written consent of enrolled participants, the corresponding envelopes will be opened, and the treatment allocation will be revealed, Blinding description: The person who measures the intended outcomes and the person who analyzes the statistics will be unaware of the type of intervention.", "phase": "2-3", "countries": "Iran (Islamic Republic of);Iran (Islamic Republic of)", "contact_firstname": "Mohammad Sadegh Adel Mehraban", "contact_lastname": null, "contact_address": "Taleqani St., Ahmadie Clinic", "contact_email": "[email protected]", "contact_tel": "+98 21 8897 4535", "contact_affiliation": "Tehran University of Medical Sciences", "inclusion_criteria": "Inclusion criteria: RRMS patients with at least 6 months after definite diagnosis", "exclusion_criteria": "Exclusion criteria: Receiving other complementary treatments past 3 months<br>Receiving steroids in past 3 months<br>Other underlying disease<br>Inability to attend acupuncture sessions regularly", "condition": "Multiple sclerosis. <br>Multiple sclerosis", "intervention": "Intervention 1: Intervention group: Intervention group: Patients come for acupuncture for 8 weeks (2 times a week for the first 4 weeks and 1 time a week for the second 4 weeks, a total of 12 sessions). The acupuncture protocol is manual acupuncture and the points used will be ST36, ST, 40, LR2, LR3, KD3, KD6, CV4, CV6, GV20, GV24, shenmen, Yintang. All patients, including the control group, receive the routine treatment. Sterile stainless acupuncture needles (0.25 mm × 40 mm, manufactured by Zhong Yang Taihe China Co., Ltd.) are inserted vertically at a depth of 10-15 mm into the acupuncture points and left for 20 minutes. Intervention 2: Control group: The control group receives only the routine treatment.", "primary_outcome": "Score of quality of life. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Multiple sclerosis quality of life 54 (MSQOL-54) questionnaire.", "secondary_outcome": null, "secondary_id": null, "source_support": "Tehran University of Medical Sciences", "ethics_review_status": "Approved", "ethics_review_approval_date": "2024-02-24", "ethics_review_contact_name": null, "ethics_review_contact_address": "Research Ethics Committees of Neuroscience Institute - 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": 4337, "title": "Efficacy of Reducing Fatigue In Relapsing Multiple Sclerosis: An Epstein Barr Virus Treatment Trial (FIRMS EBV)", "summary": null, "published_date": "2024-08-04T00:00:00Z", "discovery_date": "2024-04-15T17:50:52.081545Z", "link": "https://anzctr.org.au/ACTRN12624000423516.aspx", "source": "WHO XML import", "relevant": null, "identifiers": { "actrn": "ACTRN12624000423516" }, "categories": [ { "category_id": 46, "category_description": "Epstein-Barr virus (EBV), also known as human herpesvirus 4, is a member of the herpes virus family. It is one of the most common human viruses. EBV is found all over the world. Most people get infected with EBV at some point in their lives. EBV spreads most commonly through bodily fluids, primarily saliva. EBV can cause infectious mononucleosis, also called mono, and other illnesses.\r\n\r\nsource: <a href=\"https://www.cdc.gov/epstein-barr/about-ebv.html\">https://www.cdc.gov/epstein-barr/about-ebv.html</a>\r\n\r\nEBV may be a leading cause of multiple sclerosis. \r\nsource: <a href=\"https://www.nature.com/articles/s41582-023-00775-5\">https://www.nature.com/articles/s41582-023-00775-5</a>", "category_name": "Epstein-Barr Virus", "category_slug": "epstein-barr-virus", "category_terms": [ "ebv", "Epstein-Barr" ], "article_count": 163 } ], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13904911", "last_refreshed_on": "2024-04-22", "scientific_title": "Fatigue In Relapsing Multiple Sclerosis Epstein Barr Virus Treatment Trial (FIRMS EBV) - Comparing Spironolactone, Tenofovir Alafenamide and Placebo", "primary_sponsor": "The University of Sydney", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ANZCTR", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "Both males and females", "date_enrollement": "2024-01-05", "target_size": "240", "study_type": "Interventional", "study_design": "Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;", "phase": "Phase 3", "countries": "Australia", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: 1. Male and female participants aged 18-65 years\r<br>2. Diagnosed with relapsing remitting Multiple Sclerosis (MS) by a neurologist\r<br>3. Expanded Disability Status Scale (EDSS) score of 6 within the last 12 months in the absence of an acute relapse or illness\r<br>4. Stable and have not received a new MS therapy in the preceding 8 weeks\r<br>5. Willingness to provide informed consent and willingness to participate and comply with the study requirements\r<br>6. Available to attend clinic visits within 1 week of each time point (baseline, Weeks 6, 16, and 20)\r<br>7. Clinical fatigue (evidenced by an FSS score greater than 4 on two occasions when completing the test serially online or in person over a fortnight)", "exclusion_criteria": "Exclusion criteria: 1. Participants treated with the MS disease-modifying therapy, cladribine (since TAF interacts with this drug) or the mood stabilizing agent, lithium (which interacts with spironolactone)\r<br>2. Treatment with angiotensin converting enzyme inhibitors or angiotensin 2 receptor blockers\r<br>3. A systemic medical disorder such as kidney disease or new diagnosis of hyper- or hypothyroidism OR any medical condition that may affect adherence to the trial intervention\r<br>4. Psychotropic medications if commenced < 4 weeks prior to study entry\r<br>5. Currently pregnant or lactating or if of child bearing potential, unwilling to take adequate contraception measures to prevent pregnancy for the duration of the clinical trial and for 2 weeks after trial completion\r<br>6. Commenced or are scheduled to commence iron supplementation\r<br>7. Acute suicidality (as per the Quick Inventory of Depressive Symptomology Tool) or a current diagnosis of substance abuse/dependence\r<br>8. Currently taking any illicit substances including any cannabis product (e.g. cannabis oil)\r<br>9. Recent gastrointestinal ulcers or renal stones\r<br>10. Epilepsy\r<br>11. Current use of any of the study drugs \r<br>12. Unable or unlikely to attend the required study visits at the required timepoints or unable to complete the study protocol\r<br>13. Lacks the capacity to consent as determined by the treating clinician", "condition": "Multiple Sclerosis;Epstein Barr Virus; <br>Multiple Sclerosis <br>Epstein Barr Virus;Neurological - Multiple sclerosis;Infection - Studies of infection and infectious agents", "intervention": "Arm 1 - Spironolactone<br>25mg oral capsule twice daily for first week, then 50mg oral capsule twice daily for next 15 weeks.<br><br>Arm 2 - Tenofovir Alafenamide (TAF)<br>25mg oral capsule daily for 16 weeks.<br><br>Both interventions will be administered as an add-on to participants' usual MS treatments (disease-modifying therapies (DMT)) and they will continue taking these as prescribed by their treating doctor.<br><br>Participants will return all unused study drug including empty bottles at study visits so that compliance can be checked.", "primary_outcome": "Fatigue[Modified Fatigue Impact Scale Baseline and after 16 weeks of treatment]", "secondary_outcome": "Fatigue[Fatigue Severity Scale Baseline and after 16 weeks of treatment]", "secondary_id": "None", "source_support": "National Health and Medical Research Council", "ethics_review_status": "Approved", "ethics_review_approval_date": "2024-02-21", "ethics_review_contact_name": null, "ethics_review_contact_address": "Sydney Local Health District HREC – Concord Repatriation General Hospital", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 4336, "title": "Gait and Balance Impairment in Rare and Very Rare Neurological Diseases", "summary": "<b>Conditions</b>: Multiple Sclerosis; Parkinson Disease; Peripheral Neuropathy; Rare Diseases; Healthy; Healthy Aging\n<br /><b>Interventions</b>: Other: Questionnaires, clinical scales and instrumental tests\n<br /><b>Sponsors</b>: Istituto Auxologico Italiano; IRCCS Istituto Neurologico Carlo Besta\n<br /><b>Recruiting</b>", "published_date": "2024-08-03T00:00:00Z", "discovery_date": "2024-04-15T14:25:44.251397Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06343558", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06343558", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13879862", "last_refreshed_on": "2024-04-08", "scientific_title": "Gait and Balance Impairment in Rare and Very Rare Neurological Diseases", "primary_sponsor": "Istituto Auxologico Italiano", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "80 Years", "inclusion_gender": "All", "date_enrollement": "2023-05-30", "target_size": "200", "study_type": "Observational [Patient Registry]", "study_design": null, "phase": null, "countries": "Italy", "contact_firstname": "", "contact_lastname": "Antonio Caronni, MD, PhD", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "02 619111", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion criteria\r<br>\r<br> - Multiple sclerosis, Parkinson's disease, peripheral neuropathy of the lower limbs or\r<br> rare or ultrarare neurological disease (e.g. la Cerebellar Ataxia with Neuropathy and\r<br> Vestibular Areflexia Syndrome - CANVAS, ORPHAcode: 504476; Wilson's disease,\r<br> ORPHAcode: 905)\r<br>\r<br> - undiagnosed neurological disease, i.e. a neurological disease that remains unknown\r<br> after a full diagnostic assessment;\r<br>\r<br> - age > 18 years;\r<br>\r<br> - ability to stand upright with no assistance and no assistive device for > 30 seconds;\r<br>\r<br> - ability to walk without assistance and with no assistive device for > 50 m;\r<br>\r<br> - ability to give their informed consent.\r<br>\r<br> Exclusion criteria\r<br>\r<br> - pregnancy or breastfeeding\r<br>\r<br> - any other medical conditions affecting by itself balance and gait (e.g. lower limb\r<br> amputation, hemiparesis due to a stroke)\r<br>\r<br> - major orthopaedic surgery (e.g. hip or knee replacement).\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Parkinson Disease;Peripheral Neuropathy;Rare Diseases;Healthy;Healthy Aging", "intervention": "Other: Questionnaires, clinical scales and instrumental tests", "primary_outcome": "Balance (Mini-BESTest);Balance (Timed Up and Go test);Gait speed;Gait analysis - kinematic - stride length;Gait analysis - kinematic - duration;Gait analysis - kinematic - width of the base of support;Gait analysis - kinematic - dorsal ankle angle;Gait analysis - dynamic - reaction force;Gait analysis - dynamic - ankle power;Gait analysis - dynamic - energy;Posturography - static - centre of pressure position;Posturography - static - centre of mass position;Posturography - dynamic - centre of pressure position;Posturography - dynamic - centre of mass position", "secondary_outcome": null, "secondary_id": "24C302", "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": 4335, "title": "Functional Balance Intervention in Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Behavioral: Functional Balance Intervention; Behavioral: Stretching\n<br /><b>Sponsors</b>: University of Illinois at Chicago\n<br /><b>Not yet recruiting</b>", "published_date": "2024-03-26T00:00:00Z", "discovery_date": "2024-04-13T04:26:07.623899Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06341023", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06341023", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13961040", "last_refreshed_on": "2024-05-13", "scientific_title": "Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis", "primary_sponsor": "University of Illinois at Chicago", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "90 Years", "inclusion_gender": "All", "date_enrollement": "2024-06-14", "target_size": "120", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).", "phase": "N/A", "countries": "United States", "contact_firstname": "; ;", "contact_lastname": "Tanvi Bhatt, PhD;Rudri Purohit, MS;Tanvi Bhatt, PhD", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";312-413-9772;312-355-4443", "contact_affiliation": "University of Illinois at Chicago;", "inclusion_criteria": "<br> Inclusion criteria:\r<br>\r<br> Telephone screening (for Study 1 and 2):\r<br>\r<br> - Age group: Adults between 55-80 years of age\r<br>\r<br> - Self-reported diagnosis of Multiple Sclerosis\r<br>\r<br> - Be on stable disease modifying therapy (DMT) for =6 months.\r<br>\r<br> - Has not received physical therapy or occupational therapy services for =6 months.\r<br>\r<br> - Able to stand up from a chair independently with or without use of handrails.\r<br>\r<br> - Score between 25-75% on the 12-item Multiple Sclerosis walking scale, which indicates\r<br> that they have mobility disability or walking dysfunction.\r<br>\r<br> - Absence of any other acute or chronic neurological (Stroke, Parkinson's disease),\r<br> cardiopulmonary, musculoskeletal (injuries like fractures or dislocations or\r<br> pathologies like Rheumatoid arthritis) or systemic diagnosis, all conditions that\r<br> except Multiple Sclerosis that can directly impact individual's ability to stand and\r<br> walk.\r<br>\r<br> - Can understand and communicate in English because the protocol will only be delivered\r<br> in English.\r<br>\r<br> - Be willing to complete all aspects of the study protocol (outcome assessments, 4-month\r<br> training, accelerometer wear, etc.).\r<br>\r<br> - Individuals who give a positive response (Yes) to the question of whether the\r<br> participants feel that their memory or thinking skills worsened lately?\" will be\r<br> marked as potential individuals with mild cognitive impairment.\r<br>\r<br> - Must be willing to come to the lab for 2 times a week for four months for training\r<br> sessions (for Study 1 participants only).\r<br>\r<br> - Must have access to the internet and must be willing to attend weekly zoom calls and\r<br> undergo monthly tests on zoom (for Study 2 participants only).\r<br>\r<br> - Must be living with a family member (for Study 2 participants only).\r<br>\r<br> - Must have a helper buddy to be present during the home exercise sessions and monthly\r<br> progression evaluation Zoom calls with the researcher (for Study 2 participants only).\r<br>\r<br> In-person Screening (for Study 1 and 2):\r<br>\r<br> - Must have mobility Disability, a score of 4.0-6.5 on the Expanded Disability Status\r<br> Scale (EDSS).\r<br>\r<br> - Must have mild cognitive impairment, a score of 18-25 on the Montreal Cognitive\r<br> Assessment (MoCA) and score >1 but less than 2.5 standard deviations on 2 or more\r<br> measures within at least 1 domain (e.g., memory, language, attention/processing speed,\r<br> executive function, visuospatial abilities) on the established criteria named \"Jak /\r<br> Bondi\" criteria.\r<br>\r<br> - Must be physically inactive, a score <14 on the questionnaire named \"Godin leisure\r<br> time\" questionnaire.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> Telephone Screening (for Study 1 and 2):\r<br>\r<br> - MS Relapse or exacerbation =3 months\r<br>\r<br> - Recent major surgery (< 6 months) or hospitalization (< 3 months) that might interfere\r<br> with testing/training.\r<br>\r<br> - Complaints of shortness of breath or uncontrolled pain (>3/10 on visual analogue scale\r<br> (VAS)) at rest to avoid complications/injuries during testing/training.\r<br>\r<br> - Uncontrolled/untreated hypertension or diabetes to avoid cardiovascular complications\r<br> during testing/training.\r<br>\r<br> - Self-reported history of bone fracture in the last six months to avoid\r<br> complications/injuries during testing/training.\r<br>\r<br> - Self-reported disability in performing activities of daily living (with or without\r<br> assistive device).\r<br>\r<br> - Self-reported diagnosis of epilepsy or uncontrolled seizures in the past year.\r<br>\r<br> - Intake of sedative drugs (diazepam, lorazepam, midazolam, propofol, dexmedetomidine,\r<br> thiopental) that might interfere with testing/training.\r<br>\r<br> - Intake of any Alzheimer's Disease (AD) or dementia modifying medications (donepezil,\r<br> rivastigmine, galantamine, aducanumab) as well as other anticipated FDA approved drugs\r<br> that may be approved during the next 5 years. Individuals who are enrolled in any AD\r<br> disease modifying drugs trials that might interfere with testing/training or affect\r<br> the ability to understand instructions will also be excluded.\r<br>\r<br> - Intake of anti-depressants or anxiety drugs.\r<br>\r<br> - Moderate or high risk for possible injury or death when undertaking strenuous or\r<br> maximal exercise as indicated by reporting a 'YES' on any of the seven items on the\r<br> Physical Activity Readiness Questionnaire. These participants will be excluded from\r<br> participation, and further advised to seek medical guidance from their physician.\r<br>\r<br> - People with severe cognitive impairment will be excluded, indicated by a score of 18\r<br> or higher on the Telephone Interview for Cognitive status (TICS-M). These participants\r<br> will be advised to seek medical guidance from the physician.\r<br>\r<br> - Currently undergoing any cognitive rehabilitation for higher brain functions or\r<br> physical rehabilitation.\r<br>\r<br> - Pacemaker users\r<br>\r<br> In-person Screening (for Study 1 and 2):\r<br>\r<br> - Cardiovascular abnormalities: Heart Rate > 85% of age-predicted maximal heart rate,\r<br> systolic blood pressure (SBP) > 165 millimetre of mercury (mmHg), diastolic blood\r<br> pressure > 110 mmHg during rest OR systolic blood pressure < 90 mmHg and/or mean\r<br> arterial blood pressure < 65 mmHg OR oxygen saturation < 95% during rest.\r<br>\r<br> - Osteopenia (a T - Score of =-2.5 on heel ultrasound). Participants with a score = -2.5\r<br> will be advised to seek medical guidance from their physician.\r<br>\r<br> - Loss of protective peripheral sensations (inability to perceive 5.07/10 g on the\r<br> Semmes Monofilament testing).\r<br>\r<br> - Global aphasia (A score of <71% on the Mississippi Aphasia Scoring test)\r<br>\r<br> - Peripheral nerve injuries (traumatic nerve lacerations, pathological nerve damage).\r<br>\r<br> - High fall-risk, <40/56 on Berg Balance Scale (for Study 2 participants only)\r<br>\r<br> - Inability to walk 1 block with or without an assistive device (for Study 2\r<br> participants only)\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Behavioral: Functional Balance Intervention;Behavioral: Stretching", "primary_outcome": "Change in physical function;Change in cognitive function;Change in dual task balance performance;Change in dual task gait performance;Change in measured community mobility;Change in self-reported community mobility;Change in self-reported quality of Life", "secondary_outcome": "Change in walking performance;Change in walking speed;Change in balance confidence;Change in functional independence", "secondary_id": "2023-1430", "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": 4334, "title": "Reproductive Options in Inherited Skin Diseases", "summary": "<b>Conditions</b>: Ichthyosis; Palmoplantar Keratoses; Epidermolysis Bullosa; Ectodermal Dysplasia; Basal Cell Nevus Syndrome; Birt-Hogg-Dube Syndrome; Tuberous Sclerosis; Xeroderma Pigmentosum; Cutis Laxa; Albinism\n<br /><b>Sponsors</b>: Maastricht University Medical Center\n<br /><b>Enrolling by invitation</b>", "published_date": "2024-03-26T04:00:00Z", "discovery_date": "2024-04-09T13:25:51.343946Z", "link": "https://clinicaltrials.gov/study/NCT06330324?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06330324", "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": 4333, "title": "Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis", "summary": null, "published_date": "2017-01-19T00:00:00Z", "discovery_date": "2024-04-08T17:14:12.293294Z", "link": "https://clinicaltrials.gov/ct2/show/NCT03032601", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT03032601" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13873664", "last_refreshed_on": "2024-04-08", "scientific_title": "Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis", "primary_sponsor": "Thomas Jefferson University", "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": "2017-01-05", "target_size": "55", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Daniel A Monti, MD, MBA", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Thomas Jefferson University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Clinical diagnosis of relapsing remitting MS or progressive MS who do not plan to\r<br> start a medication during the study, or on stable disease modifying medication\r<br> (interferon, glatiramer, dimethyl fumarate, teriflunomide).\r<br>\r<br> - Age 18 years old to no upper limit\r<br>\r<br> - Physically independent, ambulatory\r<br>\r<br> - Women of childbearing potential will confirm a negative pregnancy test and must\r<br> practice effective contraception during the period of pilot study. In addition, male\r<br> subjects who have a partner of childbearing age should practice effective\r<br> contraception.\r<br>\r<br> - Participants must be able to complete study procedures in the greater Philadelphia\r<br> area.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients are excluded who have received treatment with intravenous steroids within the\r<br> past 90 days for reasons other than MS\r<br>\r<br> - Previous brain surgery that would interfere with determination of cerebral metabolism\r<br> or structure on the FDG PET-MRI.\r<br>\r<br> - Score on Mini-Mental Status examination of 20 or lower.\r<br>\r<br> - Wheelchair-bound or bed-ridden, non-ambulatory.\r<br>\r<br> - Intracranial abnormalities that may complicate interpretation of the brain scans\r<br> (e.g., stroke, tumor, vascular abnormality affecting the target area).\r<br>\r<br> - History of head trauma with loss of consciousness > 48 hours.\r<br>\r<br> - History of asthma requiring daily medications for adequate management.\r<br>\r<br> - Any medical disorder or physical condition that could reasonably be expected to\r<br> interfere with the assessment of MS symptoms, or with any of the study assessments\r<br> including the PET-MRI imaging.\r<br>\r<br> - Patients with evidence of a significant psychiatric disorder by history/examination\r<br> that would prevent completion of the study will not be allowed to participate.\r<br>\r<br> - Patients with current alcohol or drug abuse\r<br>\r<br> - Pregnant or lactating women.\r<br>\r<br> - Enrollment in active clinical trial/ experimental therapy within the prior 30 days.\r<br>\r<br> - Pending surgery during the course of the study.\r<br>\r<br> - Patients taking medications that might interact with NAC involved in this study will\r<br> be evaluated on a case by case basis by the PI or study physician. These medications\r<br> include: Medications for high blood pressure; Medications that slow blood clotting;\r<br> Medications for diabetes; Nitroglycerin.\r<br>\r<br> - Patients with history of pulmonary hypertension.\r<br>\r<br> - Any neurological, psychiatric, or medical condition that might affect the distribution\r<br> of the radiopharmaceutical in the body or brain (as determined by Investigator)\r<br>\r<br> - Currently using medications that might alter the distribution of radiopharmaceuticals\r<br> in - -the body or brain (as determined by Investigator)\r<br>\r<br> - Patient exceeds the weight limit of the table\r<br>\r<br> - Claustrophobia that would prevent completion of imaging studies\r<br>\r<br> - Glucose level that would interfere with the FDG PET scan\r<br>\r<br> - Any additional contraindications for MRI; Has metallic objects (e.g., pacemakers) in\r<br> the body\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Dietary Supplement: N-acetyl Cysteine", "primary_outcome": "Changes in the metabolic activity in the brain, and improved parameters with regard to the inflammation associated with the active lesions based on both MRI and PET findings.", "secondary_outcome": "Mini-Mental Status examination (MMSE);Multiple Sclerosis Quality of Life Inventory (MSQLI);Health Status Questionnaire (SF-36) standard form;Modified Fatigue Impact Scale (MFIS) standard form;MOS Pain Effects Scale (PES);Bladder Control Scale (BLCS);Bowel Control Scale (BWCS);Impact of Visual Impairment Scale (IVIS);Perceived Deficits Questionnaire (PDQ) standard form;Mental Health Inventory (MHI) standard form;MOS Modified Social Support Survey (MSSS) standard form;Sexual Satisfaction Scale (SSS);Kurtzke Expanded Disability Status Scale (EDSS)", "secondary_id": "16D.672", "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 } ] }