Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=3
{ "count": 4827, "next": "http://api.gregory-ms.com/trials/?format=api&page=4", "previous": "http://api.gregory-ms.com/trials/?format=api&page=2", "results": [ { "trial_id": 4325, "title": "Bioequivalence study of Cladribine 10 mg tablet in relapsing forms of multiple sclerosis patients", "summary": null, "published_date": "2024-06-03T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.602540Z", "link": "http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=99897", "source": "WHO XML import", "relevant": null, "identifiers": {}, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13830661", "last_refreshed_on": "2024-04-01", "scientific_title": "A Prospective, Randomized, Open Label, Balanced, Single Dose, Two Stage, Two-Treatment, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Cladribine Tablet (Intas \nPharmaceuticals Ltd.) Compared with Mavenclad® (EMD Serono, Inc.) in Patients with Relapsing \nForms of Multiple Sclerosis. - NIL", "primary_sponsor": "Invitro Research Solutions Private Limited", "retrospective_flag": "Yes", "date_registration": null, "source_register": "CTRI", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": "2024-03-21", "target_size": "30", "study_type": "BA/BE", "study_design": "Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label", "phase": "N/A", "countries": "India", "contact_firstname": "T Vijaya Bhaskar", "contact_lastname": null, "contact_address": "Invitro Research Solutions Pvt. Ltd, Clinical Development\nDepartment, Clinical Operations Division, 2nd Floor No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,", "contact_email": "[email protected]", "contact_tel": "6366947473", "contact_affiliation": "Invitro Research Solutions Pvt. Ltd.,", "inclusion_criteria": "Inclusion criteria: 1 Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and in this protocol and is willing to participate in the study. <br/ ><br>2 Man or woman participant must be greater than or equal to 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent. <br/ ><br>3 Body weight greater than or equal to 40 Kg <br/ ><br>4 Participants with relapsing forms of multiple sclerosis including relapsing-remitting disease and active secondary progressive disease as per McDonald’s criteria, who are eligible and planned <br/ ><br>to receive for the first cycle of either first or second treatment course of oral cladribine tablet as per investigator judgement. <br/ ><br>NOTE: If a participant is receiving their Second Course/First Cycle of oral cladribine under <br/ ><br>current study, then it must be at least 43 weeks after the last dose of First Course/Second Cycle. <br/ ><br>5 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: <br/ ><br>a. Is not a woman of childbearing potential (WOCBP) <br/ ><br>OR <br/ ><br>a. Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly <br/ ><br>effective (with a failure rate of less than 1% per year), with low user dependency when used <br/ ><br>consistently and correctly <br/ ><br>b. during the intervention phase and for at least 6 months after the last dose of study <br/ ><br>intervention and agrees not to donate eggs (ova, oocytes) for the purpose of <br/ ><br>reproduction during the study and for a period of at least 6 months after the last dose <br/ ><br>of study intervention. The investigator should evaluate the effectiveness and the <br/ ><br>potential for contraceptive method failure (e.g., noncompliance, recently initiated) of <br/ ><br>the contraceptive method in relationship to the first dose of study intervention. <br/ ><br>c. A WOCBP must have a negative highly sensitive serum pregnancy test at screening <br/ ><br>and urine pregnancy test before each dosing. <br/ ><br>d. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum <br/ ><br>pregnancy test is required. In such cases, the participant must be excluded from <br/ ><br>participation if the serum pregnancy result is positive <br/ ><br>The investigator is responsible for review of medical history, menstrual history, and recent <br/ ><br>sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ ><br>6 Male participants are eligible to participate if they agree to the following during the intervention phase and for at least 6 months after the last dose of study intervention: <br/ ><br>a. Must agree not to donate sperm for the purpose of reproduction <br/ ><br>PLUS EITHER: <br/ ><br>b. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent <br/ ><br>on a long-term and persistent basis) and agree to remain abstinent <br/ ><br>OR <br/ ><br>a. Must agree to use contraception /barrier as detailed below <br/ ><br>b. A male participant must wear a condom when engaging in any activity that allows for <br/ ><br>passage of ejaculate to another person. <br/ ><br>c. Male participants should also be advised of the benefit for a female partner to use a <br/ ><br>highly effective method of contraception as condom may break or leak when having <br/ ><br>sexual intercourse", "exclusion_criteria": "Exclusion criteria: 1 Documented medical history of uncontrolled, clinically significant intercurrent cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. <br/ ><br>2 Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/excipients thereof (refer to the US prescribing information of Mavenclad), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study. <br/ ><br>3 Contraindications to the use of study intervention per latest US prescribing information of Mavenclad <br/ ><br>4 Current unstable liver or biliary disease with Child-Pugh score less than 6 at screening visit. <br/ ><br>5 Participant with clinically significant current cardiac conditions like serious cardiac arrhythmia not controlled by adequate medication, electrocardiographic evidence of acute ischemic abnormalities, or any other cardiac illness that could lead to a safety risk to the participant in the opinion of the investigator. <br/ ><br>6 Positive for HIV, or positive Hepatitis C antibody test or Hepatitis B surface antigen test and/or core antibody test for IgG and/or IgM. <br/ ><br>7 Evidence of active or latent tuberculosis (TB) as detected by local standard of practice such as imaging and/or positive QuantiFERON-TB Gold test. <br/ ><br>8 Presence of any clinically significant active systemic bacterial, viral or fungal infections (acute or chronic) as assessed by investigator at randomization. Randomization can be delayed till resolution or control of infection as assessed by investigator allowing use of cladribine tablet. <br/ ><br>9 Live or live-attenuated vaccine(s) within 6 weeks prior to randomization, or plans to receive such vaccines during the study. Participants must agree to avoid live or live-attenuated vaccine(s) after study till white blood cell counts are within normal limits. <br/ ><br>10 Current evidence or history of malignancy within the past 3 years except for (a) basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of disease for 3 years; or (b) any malignancy which is considered cured with minimal risk of recurrence AND whose natural history or treatment does not have the potential as judged by the investigator to interfere with the safety of the study intervention are eligible for this study. <br/ ><br>11 Participants with neurological findings consistent with progressive multifocal leukoencephalopathy (PML), or confirmed PML. Baseline MRI is required during screening period if not done in past 3 months prior to administration of study intervention if it is the participant’s first treatment course. <br/ ><br>12 Received a study intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to randomization, whichever is longer. <br/ ><br>13 Participant’s clinical condition would not be feasible for pharmacokinetic assessment as determined by investigator. <br/ ><br>14 Unable to swallow solid, oral dosage forms whole with the aid of water (participants must not chew, divide, dissolve, or crush the study intervention) <br/ ><br>", "condition": "Health Condition 1: G35- Multiple sclerosis", "intervention": "Intervention1: Cladribine tablet 10 mg: Manufactured by: Intas <br>Pharmaceuticals Limited India<br>The recommended cumulative dosage of cladribine tablet is 3.5 mg per kg body <br>weight administered orally and divided into 2 yearly treatment courses (1.75 mg per <br>kg per treatment course). Each treatment course is divided into 2 treatment cycles: Each cycle lasting 4 to 5 consecutive days. Do not administer more <br>than 20 mg/day.<br>Control Intervention1: MAVENCLAD® (Cladribine) tablets <br>10 mg: Manufactured for: : EMD Serono, Inc., Rockland, MA 02370.<br>The recommended cumulative dosage of cladribine tablet is 3.5 mg per kg body weight administered orally and divided into 2 yearly treatment courses (1.75 mg per kg per treatment course). Each treatment course is divided into 2 treatment cycles: Each cycle lasting 4 to 5 consecutive days. Do not administer more than 20 mg/day.<br>", "primary_outcome": "Following primary pharmacokinetic parameters <br/ ><br>will be assessed: <br/ ><br>a. Cmax and AUC0-tTimepoint: After First Dose", "secondary_outcome": "Following secondary pharmacokinetic <br/ ><br>parameters will be assessed: <br/ ><br>a. AUC0-8, Tmax, AUC_% Exp, R2 <br/ ><br>adjusted, ?z, <br/ ><br>t1/2Timepoint: After First Dose;Frequency and/or incidence of adverse <br/ ><br>events (AE) and Serious Adverse Events <br/ ><br>(SAE)Timepoint: For entire study", "secondary_id": "iVRS-CD-23-069_Version 01, Dated 29 Dec 2023", "source_support": "Intas Pharmaceuticals Limited,\nCorporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad – 380054, Gujarat, India.", "ethics_review_status": "Approved;Approved;Approved", "ethics_review_approval_date": null, "ethics_review_contact_name": ";;", "ethics_review_contact_address": "Independent Ethics Committee Namaste Integrated Services;Penta-Med Ethics Committee;Rajalakshmi Hospital Institutional Ethics Committee", "ethics_review_contact_phone": ";;", "ethics_review_contact_email": ";;", "results_date_completed": null, "results_url_link": null }, { "trial_id": 4324, "title": "Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis; Remitting Relapsing Multiple Sclerosis\n<br /><b>Interventions</b>: Drug: Ifenprodil; Drug: Placebo\n<br /><b>Sponsors</b>: Assistance Publique - Hôpitaux de Paris\n<br /><b>Not yet recruiting</b>", "published_date": "2024-12-03T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.547385Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06330077", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06330077", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13828857", "last_refreshed_on": "2024-04-01", "scientific_title": "A Phase 2 Trial Assessing Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis", "primary_sponsor": "Assistance Publique - Hôpitaux de Paris", "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": "2024-03-15", "target_size": "60", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).", "phase": "Phase 2", "countries": "France", "contact_firstname": "", "contact_lastname": "Bruno STANKOFF, MD", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "0171970659", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> -\r<br>\r<br> Patients:\r<br>\r<br> 1. Signed informed consent form at pre-inclusion visit\r<br>\r<br> 2. Age between 18 years and 55 years, inclusive, at time of pre-inclusion visit.\r<br>\r<br> 3. Patient with a RR form of MS according McDonald criteria 2017 at pre-inclusion visit\r<br>\r<br> 4. Able to comply with the study protocol and to understand the purpose and risks of the\r<br> study, in the investigator's judgment\r<br>\r<br> 5. Social security registration (AME excluded) at time of pre-inclusion visit\r<br>\r<br> 6. At least one eye with a P100 latency > 118ms on visual evoked potential at baseline\r<br> (defining the qualifying eye) at time of pre-inclusion visit\r<br>\r<br> 7. Retinal nerve fibre layer thickness on spectral-domain optical coherence tomography\r<br> [OCT] > 70 µm in the VEP qualifying eye (to increase the likelihood that the number of\r<br> surviving axons is sufficient to provide the substrate for remyelination to occur) at\r<br> time of pre-inclusion visit\r<br>\r<br> 8. Patient under disease modifying therapy (first or second line approved immune active\r<br> therapy) or patient without any DMT at time of pre-inclusion visit\r<br>\r<br> 9. EDSS score = 6 at time of pre-inclusion visit\r<br>\r<br> 10. For women of childbearing potential : Efficient contraception include oral\r<br> contraception, intrauterine devices hormonal device, intrauterine hormone-releasing\r<br> system, sterilization method and other forms of contraception with failure rate <1%)\r<br>\r<br> - Healthy Volunteers\r<br>\r<br> 1. Signed informed consent form 2. Age between 18 years and 55 years, inclusive 3. All\r<br> female subjects of childbearing potential must practice effective contraception include\r<br> oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing\r<br> system, sterilization method and other forms of contraception with failure rate <1%) 4.\r<br> Able to comply with the study protocol, in the investigator's judgment 5. Social security\r<br> registration (AME excluded)\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> Patients\r<br>\r<br> 1. Patient with an acute NORB in the last 6 months prior to pre-inclusion visit\r<br>\r<br> 2. Patient with a clinical relapse other than NORB in the last 6 months prior to\r<br> pre-inclusion visit\r<br>\r<br> 3. Patients having received methylprednisolone infusion in the last 4 weeks prior to\r<br> pre-inclusion visit\r<br>\r<br> 4. Contraindications to investigational medicinal products (ifenprodil/placebo) and to\r<br> auxiliary medicinal products (gadolinium, [18F]-florbetaben)\r<br>\r<br> 5. Inability to complete an MRI (contraindications for MRI include but are not restricted\r<br> to weight = 140 kg, pacemaker, cochlear implants, presence of foreign substances in\r<br> the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study,\r<br> coronary stent implanted within 8 weeks prior to the time of the intended MRI,\r<br> contraindication to gadoteric acid etc.).\r<br>\r<br> 6. PET imaging performed in the past 12 months as part of clinical research\r<br>\r<br> 7. History or incidental discovery of significant cardiac conduction block\r<br>\r<br> 8. Orthostatic hypotension Syndrome define as a drop of > 20 mmHg in systolic, and/or >\r<br> 10 mmHg in diastolic between lying down and immediate standing\r<br>\r<br> 9. Known long QT syndrome or long QT syndrome (the limit is defined at 450 ms on\r<br> corrected QT) highlighted during the pre-inclusion visit\r<br>\r<br> 10. Any uncontrolled general (cancer, infectious, hematologic, hepatic, immunologic,\r<br> endocrinologic, neurologic, dermatologic, psychiatric, allergic, renal, or\r<br> cardiovascular) disease.\r<br>\r<br> 11. Creatinine clearance < 60 ml/min at pre-inclusion visit\r<br>\r<br> 12. ASAT, ALAT of alkaline phosphatase > 3-fold the upper limit normal at pre-inclusion\r<br> visit\r<br>\r<br> 13. Know Galactosemia, glucose malabsorption or lactase deficiency\r<br>\r<br> 14. Known of lack of peripheral venous access or lack of peripheral venous access\r<br> highlighted during the pre-inclusion visit\r<br>\r<br> 15. Thrombocytopenia with platelets < 100 000/mm3\r<br>\r<br> 16. Pregnancy and/or lactating women\r<br>\r<br> 17. Legal protection (curatorship or tutorship)\r<br>\r<br> 18. Deprive of freedom or under security measure\r<br>\r<br> 19. Participation in another interventional trial evaluating a health product or any\r<br> randomized trial or being in the exclusion period at the end of a previous study\r<br>\r<br> 20. Refusal to be informed in case of clinically significant incidental discovery after\r<br> MRI\r<br>\r<br> 21. Patient treated for hypertension with the following drugs blocking the\r<br> alpha-adrenergic system either in periphery (prazosine, urapidil, moxisylyte,\r<br> labetalol) or centrally (clonidine, monoxidine, methyldopa)\r<br>\r<br> Healthy Volunteers\r<br>\r<br> 1. Inability to complete an MRI (contraindications for MRI include but are not restricted\r<br> to weight = 140 kg, pacemaker, cochlear implants, presence of foreign substances in\r<br> the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study,\r<br> coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).\r<br>\r<br> 2. Impossibility to complete a PET scan: pregnancy, nuclear medicine irradiation for\r<br> clinical research in the year preceding baseline visit.\r<br>\r<br> 3. Contraindication to auxiliary medicinal products ([18F]-florbetaben)\r<br>\r<br> 4. Known presence of any neurological disorders\r<br>\r<br> 5. Pregnancy and/or lactation\r<br>\r<br> 6. Lack of peripheral venous access\r<br>\r<br> 7. Terminal renal insufficiency (Creatinin clearance < 60 ml/min)\r<br>\r<br> 8. Legal protection (curatorship or tutorship)\r<br>\r<br> 9. Deprive of freedom or under security measure\r<br>\r<br> 10. Participation in another interventional trial evaluating a health product or any\r<br> randomized trial or being in the exclusion period at the end of a previous study\r<br>\r<br> 11. Refusal to be informed in case of clinically significant incidental discovery after\r<br> MRI\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Remitting Relapsing Multiple Sclerosis", "intervention": "Drug: Ifenprodil;Drug: Placebo", "primary_outcome": "Change in P100 latency according to visual evoked potential.", "secondary_outcome": "Proportion of voxels within white matter lesions classified as remyelinating;Proportion of remyelinating voxels extracted in cortical regions from magnetization transfer imaging (MTR) acquisitions;Change in amplitude of P100 on to visual evoked potential;Change in retinal nerve fibre layer (RNFL) and ganglion cell complex (GCC) thickness on OCT;Change in blood concentration of NfL fragments;Change in the brain atrophy rate;The correlation between the change in the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions;The comparison of the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions;Incidence of adverse drug reactions", "secondary_id": "2021-003584-99;APHP200027", "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": 4323, "title": "Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study", "summary": "<b>Conditions</b>: Multiple Sclerosis; Self-Compassion\n<br /><b>Interventions</b>: Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)\n<br /><b>Sponsors</b>: Robert Simpson\n<br /><b>Not yet recruiting</b>", "published_date": "2024-03-19T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.446922Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06337903", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06337903", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13879483", "last_refreshed_on": "2024-04-08", "scientific_title": "Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study", "primary_sponsor": "Robert Simpson", "retrospective_flag": "Yes", "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": "2024-05-01", "target_size": "45", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).", "phase": "N/A", "countries": "Canada", "contact_firstname": "; ;", "contact_lastname": "Robert Simpson, PhD;Robert Simpson, PhD;Robert Simpson, PhD", "contact_address": null, "contact_email": ";[email protected];", "contact_tel": ";416-360-4000;", "contact_affiliation": "Unity Health Toronto;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Aged 18 years or older\r<br>\r<br> 2. Able to understand spoken and written English\r<br>\r<br> 3. Have a neurologist-confirmed diagnosis of multiple sclerosis\r<br>\r<br> 4. Willing to take place in an Mindful Self Compassion course\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Cognitive impairment (<26 on the Montreal Cognitive Assessment)\r<br>\r<br> 2. Severe active mental health impairment (psychosis, suicidality)\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Self-Compassion", "intervention": "Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)", "primary_outcome": "Recruitment;Retention;Adherence;Follow-up rates", "secondary_outcome": "Stress;Anxiety;Depression;Self-compassion;Emotion Regulation;Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29);Participant Experiences and Perspectives;Adjustment", "secondary_id": "Self-compassion for PwMS", "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": 4322, "title": "Study to check the efficacy of Panchakarma procedures in the management of Multiple sclerosis", "summary": null, "published_date": "2024-03-20T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.414060Z", "link": "http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=102035", "source": "WHO XML import", "relevant": null, "identifiers": {}, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13831522", "last_refreshed_on": "2024-04-01", "scientific_title": "A Pilot Study to evaluate the Clinical Efficacy of an Ayurvedic Treatment Module in the Management of Multiple Sclerosis ( Sarvanga Gatavata) - NIL", "primary_sponsor": "All India Institute of Ayurveda", "retrospective_flag": "Yes", "date_registration": null, "source_register": "CTRI", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": "2024-05-15", "target_size": "15", "study_type": "Interventional", "study_design": "Single Arm Study Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label", "phase": "Phase 2/ Phase 3", "countries": "India", "contact_firstname": "ProfDr Anandaraman PV", "contact_lastname": null, "contact_address": "Room No.725 Department of Panchakarma, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, South Delhi 110076 India", "contact_email": "[email protected]", "contact_tel": "9895174060", "contact_affiliation": "All India Institute of Ayurveda", "inclusion_criteria": "Inclusion criteria: 1. Patients who are fit to undergo Snehapana, Virechana, Swedana,Basti and Nasya Karma. <br/ ><br>2.Diagnosed cases of Multiple Sclerosis with MRI , continuing allopathic medication and EDSS score less than 8. <br/ ><br>3. ICD code: G - 35 <br/ ><br>4. Socio- economic status: All", "exclusion_criteria": "Exclusion criteria: 1. Cardiac disease, pulmonary tuberculosis, severe lung disease, diabetes and pregnant women, exposed skin related disease. <br/ ><br>2.EDSS score more than 8 .", "condition": "Health Condition 1: G35- Multiple sclerosis", "intervention": null, "primary_outcome": "Reduction in spasticity using MSSS 88 SCALE. <br/ ><br> <br/ ><br>Timepoint: (Day-0) (Day-22) (Day-38) (Day-52) <br/ ><br> <br/ ><br>", "secondary_outcome": "To determine the change in Quality of life using MSQL54 <br/ ><br>instrument, Visual Analog score and EDSS. <br/ ><br>Timepoint: (Day-0) (Day-22) (Day-38) (Day-52) <br/ ><br>", "secondary_id": "NIL", "source_support": "All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076", "ethics_review_status": "Approved", "ethics_review_approval_date": "2023-11-29", "ethics_review_contact_name": null, "ethics_review_contact_address": "Division of Translational Research & Biostatistics, All India Institute of Ayurveda", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 4321, "title": "Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis; Major Depressive Disorder; Treatment Resistant Depression\n<br /><b>Sponsors</b>: University of Utah\n<br /><b>Recruiting</b>", "published_date": "2024-03-15T00:00:00Z", "discovery_date": "2024-04-08T13:26:43.350203Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06329414", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06329414", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13828806", "last_refreshed_on": "2024-04-01", "scientific_title": "Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis", "primary_sponsor": "University of Utah", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "75 Years", "inclusion_gender": "All", "date_enrollement": "2024-01-16", "target_size": "12", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": ";", "contact_lastname": "Kathleen Shangraw, MD;Kathleen Shangraw, MD", "contact_address": null, "contact_email": "[email protected];", "contact_tel": "8015832500;801-583-2500", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Established diagnosis of multiple sclerosis (any subtype) by 2017 McDonald criteria\r<br>\r<br> - Established diagnosis of major depressive disorder (MDD) by DSM-5 criteria\r<br>\r<br> - Eligible for transcranial magnetic stimulation (rTMS) for depression\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - MS relapse and/or steroid use within 3 months\r<br>\r<br> - Active suicidal ideation\r<br>\r<br> - History of seizure/epilepsy, brain tumor, or stroke\r<br>\r<br> - History of bipolar disorder or psychosis\r<br>\r<br> - Currently or planning to become pregnant\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Major Depressive Disorder;Treatment Resistant Depression", "intervention": null, "primary_outcome": "Feasibility of TMS treatment for MDD, per participant retention rates.;Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment.", "secondary_outcome": "Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment.;Depression remission rates will be measured using MADRS scores before and after treatment.;MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden.", "secondary_id": "00164631", "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": 4320, "title": "Trunk Control and Disability in Persons With Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Sponsors</b>: Zonguldak Bulent Ecevit University\n<br /><b>Completed</b>", "published_date": "2024-03-13T00:00:00Z", "discovery_date": "2024-04-08T05:25:50.572076Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06327789", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06327789", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13828688", "last_refreshed_on": "2024-04-01", "scientific_title": "The Relationship Between Trunk Control and Disability in Persons With Early Relapsing Multiple Sclerosis", "primary_sponsor": "Zonguldak Bulent Ecevit University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "50 Years", "inclusion_gender": "All", "date_enrollement": "2021-12-21", "target_size": "23", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Turkey", "contact_firstname": "; ; ; ; ;", "contact_lastname": "Bilge Piri Çinar;Güngör Beyza Özvar Senöz;Hasret Uçar;Serkan Özakbas;Mustafa Açikgöz;Nursena Ceylan", "contact_address": null, "contact_email": ";;;;;", "contact_tel": ";;;;;", "contact_affiliation": "Samsun University;Yüksek Ihtisas University;Zonguldak Bulent Ecevit University;Dokuz Eylul University;Zonguldak Bulent Ecevit University;Zonguldak Bulent Ecevit University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - 18-50 years old,\r<br>\r<br> - diagnosed with RRMS by an experienced neurologist\r<br>\r<br> - EDSS score = 3\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - orthopedic or sensory additional problems in the lower extremity\r<br>\r<br> - who had an interventional procedure in the last six months, and had an attack in the\r<br> last three months\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": null, "primary_outcome": "Expanded Disability Status Scale (EDSS);Trunk Impairment Scale (TIS);Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA);Step Length (cm);Stride Length (cm);Step Width (cm);Cadence (steps/min);Velocity (m/s);Step time (s);Stride time (s);Timed 25-Foot Walk Test (T25FW);Nine-Hole Peg Test (9HPT)", "secondary_outcome": null, "secondary_id": "ZBEU-MS", "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": 4319, "title": "ECoG BMI for Motor and Speech Control", "summary": null, "published_date": "2018-08-21T00:00:00Z", "discovery_date": "2024-03-28T14:55:50.393410Z", "link": "https://clinicaltrials.gov/ct2/show/NCT03698149", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT03698149" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13813227", "last_refreshed_on": "2024-03-25", "scientific_title": "A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control", "primary_sponsor": "Karunesh Ganguly", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "21 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2018-11-09", "target_size": "3", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).", "phase": "N/A", "countries": "United States", "contact_firstname": "; ;", "contact_lastname": "Karunesh Ganguly, MD, PhD;Adelyn Tu-Chan;Adelyn Tu-Chan", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";(415) 575-0431;415-575-0431", "contact_affiliation": "University of California, San Francisco;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Age > 21\r<br>\r<br> 2. Limited ability to use upper limbs, based on neurological examination, due to stroke,\r<br> amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury,\r<br> brainstem stroke, muscular dystrophy, myopathy or severe neuropathy.\r<br>\r<br> 3. Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be\r<br> severe enough to cause loss of independence and inability to perform activities of\r<br> daily living.\r<br>\r<br> 4. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms\r<br>\r<br> 5. Must live within a two-hour drive of UCSF\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Pregnancy or breastfeeding\r<br>\r<br> 2. Inability to understand and/or read English\r<br>\r<br> 3. Inability to give consent\r<br>\r<br> 4. Dementia, based on history, physical exam, and MMSE\r<br>\r<br> 5. Active depression (BDI > 20) or other psychiatric illness (active general anxiety\r<br> disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or\r<br> personality disorders (e.g. multiple personality disorder, borderline personality\r<br> disorder, etc.)\r<br>\r<br> 6. History of suicide attempt or suicidal ideation\r<br>\r<br> 7. History of substance abuse\r<br>\r<br> 8. Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer,\r<br> or major organ system failure\r<br>\r<br> 9. Inability to comply with study follow-up visits\r<br>\r<br> 10. Any prior intracranial surgery\r<br>\r<br> 11. History of seizures\r<br>\r<br> 12. Immunocompromised\r<br>\r<br> 13. Has an active infection\r<br>\r<br> 14. Has a CSF drainage system or an active CSF leak\r<br>\r<br> 15. Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic\r<br> stimulation (TMS) to treat a chronic condition\r<br>\r<br> 16. Has an implanted electronic device such as a neurostimulator, cardiac\r<br> pacemaker/defibrillator or medication pump, or presence of any head or neck metallic\r<br> foreign bodies\r<br>\r<br> 17. Allergies or known hypersensitivity to materials in the Blackrock NeuroPort Array\r<br> (i.e. silicone, titanium) or the PMT Subdural Cortical Electrode (silicone, platinum\r<br> iridium, nichrome)\r<br>", "exclusion_criteria": null, "condition": "ALS;SCI - Spinal Cord Injury;Stroke;Multiple Sclerosis;Muscular Dystrophies", "intervention": "Device: PMT/Blackrock Combination Device", "primary_outcome": "Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability];NIDCD Primary Objective 1;NIDCD Primary Objective 2", "secondary_outcome": "NIDCD Secondary Objective 1;NIDCD Secondary Objective 2", "secondary_id": "U01DC018671;17-23028", "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": 4318, "title": "Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease", "summary": "<b>Conditions</b>: Motor Neuron Disease, Amyotrophic Lateral Sclerosis; Motor Neuron Disease Progressive Spinal Muscle Atrophy; Primary Lateral Sclerosis; Multiple Sclerosis; Postpoliomyelitis Syndrome\n<br /><b>Interventions</b>: Procedure: 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG)\n<br /><b>Sponsors</b>: University of Dublin, Trinity College; Motor Neurone Disease Association, UK; Irish Research Council, IE; Health Research Board, IE; Research Motor Neurone, IE; Thierry Latran Foundation, FR; ALS Association, USA\n<br /><b>Recruiting</b>", "published_date": "2022-12-19T00:00:00Z", "discovery_date": "2024-03-28T14:55:30.212160Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06320444", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06320444", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13819635", "last_refreshed_on": "2024-03-25", "scientific_title": "Developing Novel Non-invasive Electrophysiological Biomarkers of Dysfunction in Spinal and Cortical Pathways and Sensorimotor Impairments in Motor Neurone Disease", "primary_sponsor": "University of Dublin, Trinity College", "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": "2023-06-15", "target_size": "240", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Ireland", "contact_firstname": "; ;", "contact_lastname": "Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN;Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN;Orla Hardiman,, BSc MB BCh BAO MD FRCPI FAAN", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";+353 1 896 4497;+353 1 896 4497", "contact_affiliation": "Academic Unit of Neurology, Trinity College Dublin, The University of Dublin;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> -\r<br>\r<br> Healthy Volunteers:\r<br>\r<br> - age and gender matched to patient groups\r<br>\r<br> - intact physical ability to take part in the experiment.\r<br>\r<br> Patients:\r<br>\r<br> - Diagnosis of ALS, PLS, PMA, SMA, Polio or MS\r<br>\r<br> - capable of providing informed consent.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> -\r<br>\r<br> Healthy Controls:\r<br>\r<br> - History of neuromuscular\r<br>\r<br> - neurological or active psychiatric disease disease\r<br>\r<br> - history of reaction or allergy to recording environments, equipment and the recording\r<br> gels.\r<br>\r<br> Patients:\r<br>\r<br> - presence of active psychiatric disease\r<br>\r<br> - any medical condition associated with severe neuropathy (e.g. poorly controlled\r<br> diabetes).\r<br>\r<br> - History of reaction or allergy to recording environments, equipment and the recording\r<br> gels.\r<br>", "exclusion_criteria": null, "condition": "Motor Neuron Disease, Amyotrophic Lateral Sclerosis;Motor Neuron Disease Progressive Spinal Muscle Atrophy;Primary Lateral Sclerosis;Multiple Sclerosis;Postpoliomyelitis Syndrome", "intervention": "Procedure: 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG)", "primary_outcome": "Biomarker of sensorimotor integration;Determination of the feasibility of sensorimotor signatures as reliable biomarkers of ALS;Non-invasive recording of the SC functional neuro-electric activity", "secondary_outcome": null, "secondary_id": "CRFSJ0297", "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": 4317, "title": "the EXPOSITION Study", "summary": "<b>Conditions</b>: Multiple Sclerosis, Relapsing-Remitting; Environmental Exposure; Lifestyle Factors\n<br /><b>Sponsors</b>: University of Pavia; National Research Council (Consiglio Nazionale delle Ricerche); IRCCS National Neurological Institute \"C. Mondino\" Foundation\n<br /><b>Not yet recruiting</b>", "published_date": "2024-09-02T00:00:00Z", "discovery_date": "2024-03-28T14:55:25.137506Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06325358", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06325358", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13820013", "last_refreshed_on": "2024-03-25", "scientific_title": "EXPOSITION (EXPosome, Oxidative Stress and InflammaTION) in Persons With Multiple Sclerosis Study", "primary_sponsor": "University of Pavia", "retrospective_flag": "Yes", "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": "2024-04-15", "target_size": "200", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Italy", "contact_firstname": "; ;", "contact_lastname": "Eleonora Tavazzi;Eleonora Tavazzi;Eleonora Tavazzi", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";0382380403;0382 380403", "contact_affiliation": "Neurological Institute-Foundation IRCCS Casimiro Mondino, Pavia, Italy;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - We will include persons with Multiple Sclerosis (pwMS) attending the Centro Sclerosi\r<br> Multipla of the IRCCS Fondazione C. Mondino of Pavia, according to the following\r<br> inclusion criteria:\r<br>\r<br> - Age = 18 years\r<br>\r<br> - Diagnosis of MS according to 2017 McDonald criteria\r<br>\r<br> - Relapsing-remitting course (RR)\r<br>\r<br> - Routine clinical examinations scheduled in the study period September 15, 2023,\r<br> to March 15, 2024,\r<br>\r<br> - Residing in the provinces of Pavia and Milano\r<br>\r<br> - Informed consent form signed\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Exclusion criteria will involve people refusing to participate in the study or people\r<br> not completely meet the inclusion criteria. Potentially eligible pwMS will be screened\r<br> by a neurologist expert in MS who will verify that all the inclusion criteria will be\r<br> fulfilled.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting;Environmental Exposure;Lifestyle Factors", "intervention": null, "primary_outcome": "microRNAs;Air quality;Nutritional assessment;Neurofilament (NfL);Cytokines;the Body Mass Index (BMI);Physical activity;Quality of life related to MS;Sleep Quality;Smoking habits;Dietary supplements use;Adherence to Mediterranean diet;Effect of diet on inflammation;waist and height ratio (WHtR);Bioelectrical impedance", "secondary_outcome": "Microbiome and biological biomarkers of oxidative stress and inflammation", "secondary_id": "0040083/23", "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": 4316, "title": "Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Other: Stoller's Afferent Nerve Stimulation (SANS)\n<br /><b>Sponsors</b>: Istituto Auxologico Italiano\n<br /><b>Recruiting</b>", "published_date": "2024-04-03T00:00:00Z", "discovery_date": "2024-03-28T14:55:24.814394Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06314412", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06314412", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13819172", "last_refreshed_on": "2024-03-25", "scientific_title": "Perineal Rehabilitation: Efficacy of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence", "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": "N/A", "inclusion_gender": "All", "date_enrollement": "2023-02-13", "target_size": "20", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "N/A", "countries": "Italy", "contact_firstname": "; ;", "contact_lastname": "Laura Perucca, MD;Laura Perucca, MD;Laura Perucca, MD", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";+39 02-619116151;+3902619116247", "contact_affiliation": "Istituto Auxologico Italiano;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - MS diagnosis according to the revised McDonalds criteria. Relapsing-remitting, primary\r<br> and secondary progressive MS forms are allowed;\r<br>\r<br> - Expanded Disability Status Scale (EDSS) between 2 and 6.5 included;\r<br>\r<br> - MiniMental State Examination = cut off 24/84 by sex/age\r<br>\r<br> Exclusion criteria:\r<br>\r<br> - Any of the following in the month before enrolment: an MS relapse; current\r<br> corticosteroids therapy because of MS; change in medicines prescribed against fatigue;\r<br> attending an intensive physical therapy program;\r<br>\r<br> - New or active lesions on a brain or spinal cord MRI scan in the 12 months before the\r<br> study enrolment;\r<br>\r<br> - Any musculoskeletal disease or any additional neurological disorder\r<br>\r<br> - Urinary infections or surgery in perineal regions\r<br>\r<br> - Skin lesions or carcinoma in situ\r<br>\r<br> - Pregnancy\r<br>\r<br> - Expanded Disability Status Scale (EDSS) = 7;\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Stoller's Afferent Nerve Stimulation (SANS)", "primary_outcome": "Measure of variation of incontinence.;Measure of variation of urinary urgency", "secondary_outcome": null, "secondary_id": "24C211", "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 } ] }