Search Results Within Category "Neurology"
5results
Computerized Registry of Patients With Venous Thromboembolism (RIETE) (RIETE)
clinicaltrials@northshore.org
ALL
Not specified
NCT02832245
Inclusion Criteria:
* Confirmed VTE (acute deep-vein thrombosis, pulmonary embolism and/or superficial venous thrombosis) by objective tests.
* Informed consent to the participation in the study, according to the requirements of the ethics committee within each hospital.
Exclusion Criteria:
* Participation in a therapeutic clinical trial with an unknown drug.
* Inability to the 3 month follow-up Venous Thromboembolism
Stroke Thrombectomy and Aneurysm Registry (STAR)
clinicaltrials@northshore.org
ALL
1 year to 120 years old
NCT04994756
Inclusion Criteria:
* Undergoing surgical intervention for central nervous system vascular lesion
* Between 1 and 120 years of age
Exclusion Criteria:
* No exclusion criteria PROCEDURE: Stroke/Thrombectomy/Aneurysm-specific surgical procedures
Stroke, Thromboses, Intracranial, Aneurysm, Brain
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) (ReMEDy2)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT05065216
Inclusion Criteria:
• Participant is ≥18 years of age.
• Participant weight is 50 kg to 160 kg inclusive.
• Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset.
• Participant has NIHSS ≥5 and ≤ 15 at approximately the time of randomization.
• Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant's representative.
• Participant and/or legally authorized representative is able to provide informed consent.
• Participant is willing and able to comply with the study protocol, in the Investigator's judgment.
Exclusion Criteria:
• Participant has any evidence of intracranial hemorrhage.
• Participant has received or will receive fibrinolytics for their current AIS.
• Participant has image findings with symptomatic large vessel occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA, vertebral or basilar artery (BA).
• Participant has large core of established infarction defined as ASPECTS 0-4.
• Participant has or will receive MT for their current AIS.
• Participant has imaging findings and/or symptoms consistent with a posterior circulation stroke.
• Participant has any recorded SBP \< 100 mm HG or MAP \<65 mm Hg; MAP = DBP + \[1/3 (SBP - DBP)\] (measured with noninvasive BP cuff type monitor) after stroke symptom onset and prior to randomization.
• Participant is currently prescribed angiotensin-converting enzyme inhibitor (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment through Day 29 ±1 day (8 days after last treatment).
• If participant is currently prescribed an ACEi and the last dose of the ACE inhibitor medication is reported to have been taken \< 24 hours before start of IV study drug infusion as stated by participant or participant's representative.
• Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization.
• Life expectancy estimated at ≤ 1 year prior to enrollment.
• Participant has clinical evidence of an active infection at the time of enrollment requiring parenteral treatment or hospitalization to monitor or manage the infection. NOTE: Treatment of uncomplicated infections with oral antibiotics would not be an exclusion (example treatment of an uncomplicated urinary tract infections or sinus infections with oral antibiotics would not be an exclusion).
• Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
• Participant is pregnant or nursing. NOTE: Participants who agree to stop nursing may be considered for inclusion at the discretion of the Investigator.
• Participants of child-bearing potential must agree to use medically acceptable contraceptive measures to prevent pregnancy. All participants of childbearing potential (defined as sexually mature participants who have had menses within the preceding 24 months and have not undergone permanent sterilization methods such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) must have a negative serum pregnancy test performed locally at screening. Participants of childbearing potential must agree not to attempt to become pregnant or undergo in vitro fertilization. If participating in sexual activity that could lead to pregnancy, participants must use 2 reliable methods (1 per partner is acceptable) of contraception simultaneously while receiving protocol-specified medication and during the study follow-up period. Participants participating in sexual activity must agree to use, or for their partner to use highly effective birth control methods (those with a failure rate of less than 1% per year when used consistently and correctly) until they have completed the study (after the Day 90 visit). Such methods include: * Combined (estrogen and progesterone containing) hormonal oral, intravaginal, or transdermal contraception associated with the inhibition of ovulation * Progesterone-only oral, injectable, or implantable hormonal contraception associated with the inhibition of ovulation * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner * Sexual abstinence Participants who are not of reproductive potential (who have been postmenopausal for more than 24 consecutive months or have undergone hysterectomy, bilateral oophorectomy) are not required to use contraception. Participants are prohibited from sperm donation. NOTE: A negative serum pregnancy test will be documented during screening if a participant is of child-bearing potential.
• Participant is currently participating in or has participated in a study using an investigational device or drug or received an investigational drug or investigational use of a licensed drug within 30 days prior to screening.
• Participant does not have sufficient venous access for infusion of study treatment or blood sampling.
• Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
• Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
DRUG: Recombinant human tissue kallikrein
Acute Stroke, Ischemic Stroke, Stroke
acute, ischemic, stroke, AIS, tPA, LVO, MT, KLK1, Kallikreins
A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work (MOBILIZE)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT06290128
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).
* Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.
* Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.
* Immunoglobulin-refractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening
* Corticosteroid-refractory subgroup: Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening
* Participant has an INCAT score of 2 to 9
* Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months
* Participant may be receiving low-dose oral corticosteroids (≤20 mg/day of prednisone or equivalent)
* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥ 2 points at Screening
* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention
* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant
* A body weight at Screening of 35 kg to 154 kg (77 to 340 lbs), inclusive
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Polyneuropathy of other causes, including but not limited to: acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to Immunoglobulin M (IgM) monoclonal gammopathy, POEMS syndrome, and lumbosacral radiculoplexus neuropathy.
* Sensory CIDP, Distal CIDP and focal CIDP variants.
* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments
* Poorly controlled diabetes
* Serious infections requiring hospitalization within 30 days prior to Screening and any active infection requiring antimicrobial treatment during screening or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections)
* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti-double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.
* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per Investigator's judgment.
* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on C-SSRS during screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.
* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse
* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk
* Participant has recently received immunoglobulins (IVIg or SCIg)
* Recent treatment with plasma exchange
* Prior treatment with riliprubart
* Prior treatment with (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine
* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation
* Prior treatment with B-cell-depleting agents such as rituximab within 6 months
* Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer
* Treatment within 6 months prior to dosing with immunosuppressive/ chemotherapeutic medications, such as cyclophosphamide, methotrexate, tacrolimus, interferon, or tumor necrosis factor (TNF)-α inhibitors. Certain immunosuppressants commonly used in CIDP (azathioprine, cyclosporine, or mycophenolate mofetil) are allowed, as indicated under inclusion criterion.
* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening)
* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening
* Any screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial
* Positive result of any of the following tests:
* Hepatitis B surface antigen (HBsAg).
* Anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \[anti-HBs Ab\] are also positive, indicating natural immunity).
* Anti-hepatitis C virus (anti-HCV) antibodies (participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained).
* Anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.
* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
* Accommodation in an institution because of regulatory or legal order; eg, imprisoned or legally institutionalized
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potential risk for noncompliance to study procedures
* Participants are employees at the clinical study site or other individuals directly involved in the conduct of the study, or immediate family member of such individuals
* Any country related specific regulation that would prevent the participant from entering the study
* Recent treatment with efgartigimod
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. DRUG: Riliprubart, DRUG: Placebo, DRUG: Riliprubart, DRUG: Placebo
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Polyneuropathy, Inflammatory Demyelinating, Chronic
Autoimmune Diseases, Neurologic, Autoimmune Disorders, Nervous System, Peripheral Nerves Disease, Nervous System Diseases, Neurologic Disorders, Neurological Disorders, Complement Inhibitor, Complement Inhibitors
The CONFORM Pivotal Trial
clinicaltrials@northshore.org
ALL
18 years and over
NA
NCT05147792
Inclusion Criteria:
• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, or permanent)
• High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
• Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
• Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
• Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care
• Able to comply with the protocol-specified medication regimen and follow-up evaluations
• The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).
Exclusion Criteria:
• Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure)
• Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)
• History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
• Documented active systemic infection
• Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment
• Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
• Recent (within 30 days of index procedure) stroke or transient ischemic attack
• Recent (within 30 days of index procedure) myocardial infarction
• Vascular access precluding delivery of implant with catheter-based system
• Severe heart failure (New York Heart Association Class IV)
• Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
• Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3
• Known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or to device materials (e.g., nickel, titanium), or the subject has contrast sensitivity that cannot be adequately pre-medicated
• Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
• Unable to undergo general anesthesia
• Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years
• A condition which precludes adequate transesophageal echocardiographic assessment Echo exclusion criteria:
• Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial)
• Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE
• Left ventricular ejection fraction (LVEF) \<30%
• Moderate or large pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
• Atrial septal defect that warrants closure
• High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \> 15 mm) or large shunt (early \[within 3 beats\] and/or substantial passage of bubbles, e.g., \>20)
• Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
• Evidence of cardiac tumor
DEVICE: CLAAS, DEVICE: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
Atrial Fibrillation, Stroke