Search | Endeavor Health Clinical Trials

RECOVER-SLEEP: Platform Protocol

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06404086

Show full eligibility criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• ≥ 18 years of age at the time of enrollment
• Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization: Suspected\* case of SARS-CoV-2 infection - Three options, A through C: A. Met the clinical OR epidemiological criteria:
• Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia;
• Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presented with acute respiratory infection with a history of fever or measured fever of ≥ 38°C and cough, with onset within the last 10 days, and required hospitalization; or C. Presented with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test. Probable\* case of SARS-CoV-2 infection, defined as having met the clinical criteria above AND was a contact of a probable or confirmed case or is linked to a COVID-19 cluster; or Confirmed case of SARS-CoV-2 infection - Two options, A through B: A. Presented with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Met clinical criteria AND/OR epidemiological criteria (See suspected case A), with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test. \* Suspected and probable cases will only be allowed if they occurred before May 1, 2021, and will be limited to 10% of the study population. Otherwise, confirmed cases are required.
• New/worse sleep problems following a SARS-CoV-2 infection that have persisted for at least 12 weeks and are still present at the time of consent
• PROMIS 8a SRI or 8b SD T Score ≥ 55\*\* \*\* Screening with both the PROMIS 8a SRI and 8b SD will occur for the phenotype assessment portion of the protocol.
• Willing and able to provide informed consent, complete the surveys and clinical assessments, and return for all of the necessary follow-up visits
• Adequate method of birth control for participants of child-bearing potential

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:
• Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
• Known pregnancy, breastfeeding, or contemplating pregnancy during the study period
• Untreated sleep apnea (AHI ≥ 15 or severe sleep-related hypoxemia)
• Current night or rotating shift work
• Known history of narcolepsy prior to SARS-CoV-2 infection
• Any non-marijuana illicit drug use within 30 days of informed consent
• Known history of severe mental disorder, such as psychotic disorders and bipolar disorder
• Current or recent use (within the last 14 days) of study intervention or similar intervention to treat the underlying condition, unless a washout period is permitted per appendix\*
• Known allergy/sensitivity or any hypersensitivity to components of the study intervention or control\*
• Known contraindication(s) to study intervention including prohibited concomitant medications and without the ability to safely hold prohibited concomitant medications (see appendices)\*
• Currently receiving/using intervention from another clinical trial that could impact or mask treatment effect; refer to MOP for details
• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study (\*)If only one study intervention appendix is open at the time of enrollment. If multiple study intervention appendices are open, a participant may be excluded from any study intervention appendix based on contraindications listed in the study intervention appendix, current use of study intervention, or known allergy/sensitivity/hypersensitivity yet remain eligible for the remaining study intervention appendices.

Interventions: DRUG: Modafinil, DRUG: Modafinil Placebo, DRUG: Solriamfetol, DRUG: Solriamfetol Placebo, DRUG: Melatonin, DRUG: Melantonin Placebo, DEVICE: Tailored lighting (TL) Active, DEVICE: Tailored lighting (TL) Placebo

Conditions: Long COVID, Long COVID-19, Hypersomnia, Sleep Disturbance

Keywords: PASC

I'm interested

Paired-Ring Mitral Annuloplasty Ring Sizing Device

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06965725

Show full eligibility criteria

Interventions: DEVICE: Annuloplasy ring sizing device

Conditions: Heart Valve Diseases

Keywords: Annuloplasty Ring, Sizing methods

I'm interested

A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM (SNAPSHOT- PKP2)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 65 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06976606

Show full eligibility criteria

Conditions: Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC

Keywords: Arrhythmogenic Cardiomyopathy, ACM, Cardiomyopathy, ARVC, Arrhythmogenic Right Ventricular, Arrhythmogenic Right Ventricular Dysplasia, Genetic cardiomyopathy, Gene Therapy, PKP2 Gene, Plakophilin-2, LX2020, SNAPSHOT-PKP2, Ventricular Arrhythmia, PVCs, Sudden Cardiac Death, Cardiac Arrest

I'm interested

Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06580314

Show full eligibility criteria

Inclusion Criteria:

* Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types: * High grade serous * High grade endometrioid (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated) * Carcinosarcoma (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated), and/or * Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic), (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated) * Submission of pathology report is required * Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer * Patients must have: * Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration) * Submission of testing report is required. OR * BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©) * Submission of testing report is required * Patient must have undergone cytoreductive surgery (primary or interval) * Patients must have completed first line platinum-based therapy prior to registration: * Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated * For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy * Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle * Patients must not have received an investigational agent during their first line course of chemotherapy * Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy) * Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression and patients are neurologically stable off steroid therapy * Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent) * No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib * Age ≥ 18 * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Not pregnant and not nursing * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 9 g/dl * Creatinine clearance (CrCL) of \> 30 mL/min by the Cockcroft-Gault formula * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * No active infection requiring parental antibiotic(s) * No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube * No current inability to swallow orally administered medication * No history of myelodysplastic syndrome and/or acute myeloid leukemia * No history of allogeneic bone marrow transplant * No concomitant use of strong or moderate CYP3A inducers * No known hypersensitivity to olaparib or any of the excipients of the product

Interventions: BIOLOGICAL: Bevacizumab, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Olaparib

Conditions: Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor, FIGO Stage III Ovarian Cancer 2014, FIGO Stage IV Ovarian Cancer 2014, Ovarian Carcinoma, Ovarian Carcinosarcoma, Ovarian High Grade Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Carcinosarcoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma

I'm interested

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC) (NEC)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 2 weeks to 8 weeks old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06315738

Show full eligibility criteria

Inclusion Criteria:

• Infants born from ≥22 weeks gestational age up to and including 40 weeks gestational age; up to 40 weeks postmenstrual age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥500g and ≤3000g, as a result of prematurity and/or IUGR. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
• Bell's Stage IIA or higher medical NEC (Stages IIA - IIIA only) diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus. The clinician confirms NEC diagnosis by evaluation of the radiologic imaging for confirmed pneumatosis intestinalis. If X-ray is used and is equivocal, an ultrasound (US) may be used, if available, to confirm pneumatosis. If the clinician (Neonatologist and/or Pediatric Surgeon) has differing interpretation from that of the Radiologist, that should be documented in both the medical and research records for accuracy of NEC diagnosis.

Exclusion Criteria:

• Infants with abdominal perforation.
• Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure).
• Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect).
• Mother's receipt of any investigational product during pregnancy.
• Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia).
• Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
• Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
• Infants with anatomic defects that require surgical intervention.
• Infants with persistent pulmonary hypertension of newborn.
• Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).
• Infants who have hypoxic ischemic injury (perinatal asphyxia).
• Infants with polycythemia (at time of treatment) (\>22 g/dL).
• Positive maternal human immunodeficiency virus status.
• History of maternal drug abuse (such as amphetamines, opiates, cocaine). This does not include marijuana, or prescription medications for treatment of drug abuse.
• Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• Infants diagnosed with NEC who will require immediate surgical intervention.

Interventions: BIOLOGICAL: ST266

Conditions: Necrotizing Enterocolitis

Keywords: Necrotizing Enterocolitis, NEC

I'm interested

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 100 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06865651

Show full eligibility criteria

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.
• Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.
• CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g. medical record, clinical history, photographs) and inadequate control with H1-AH at local label approved doses at the time of randomization. The response to the provocation test for each CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1):
• CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more
• CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022c) not adequately controlled with H1-AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following: * UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization * CSU for ≥ 6 months
• Participants must be willing and able to attend the protocol defined test procedure throughout the study.

Exclusion Criteria:

• Participants who have a familial/hereditary form (e.g. familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
• Diseases, other than CSU or CINDU, with urticaria or angioedema symptoms including but not limited to: * urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), * food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant * hereditary or acquired angioedema.
• CINDU patients only: To prevent any confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and should not have a significant share of CSU symptoms (that might make the assessment of CINDU symptoms difficult) as per the investigator's judgement.
• CSU patients only: Patients should have no relevant inducible urticaria trigger
• Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
• Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known positivity for Human Immunodeficiency Virus (HIV) infection.
• Evidence of an ongoing Hepatitis C infection (defined by the detection at screening of Hepatitis C virus antibodies (anti-HCVAb) and hepatitis C ribonucleic acid (HCV-RNA) in participants who are positive for anti-HCVAb) and/or an ongoing Hepatitis B infection (defined by the detection of Hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus (HBV)-DNA at screening; participants who are positive for anti-hepatitis B core (HBc) antibodies but who are negative for antibodies against HBsAg and HBV-DNA can be included into the study if they agree to monitoring for HBsAg and HBV-DNA reactivation).
• Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.
• Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Screening), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
• Uncontrolled disease states, such as asthma, or inflammatory bowel disease, or any other disease where flares are commonly treated with oral or parenteral corticosteroids.
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
• History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN values, or abnormal urinary constituents (e.g. proteinuria, hematuria) * Evidence of urinary obstruction, or difficulty in voiding at screening * Evidence of congenital renal abnormalities with known effect on renal function * Calculated eGFR \< 60 mL/min
• Hematology parameters at screening: * Hemoglobin: \< 10 g/dL * Platelets: \< 100,000/mm3 * Leucocytes: \< 3,000/mm3 * Neutrophils:\< 1,500/mm3
• History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening
• Use of other investigational drugs s within 5 half-lives or within 30 days (for small molecules) prior to Screening or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations
• Contraindications to or hypersensitivity to remibrutinib (or its excipients or to drugs of similar chemical classes) or other substances provided to the subjects as rescue medication to control symptoms, such as antihistamines.
• Participants taking prohibited therapies as listed in Section 6.6.2. In particular patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.
• History of live or live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during the study drug treatment.
• Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d which are allowed. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
• Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC)).
• History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)
• Significant bleeding risk or coagulation disorders.
• Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before randomization as per source records.
• Pregnant or nursing (breast feeding) women.
• Women of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal unless they are permanent sterile or they are using highly effective methods of contraception during dosing for 7 days after stopping study treatment. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception * Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks prior to the first dose of study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of child-bearing potential. * Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks prior to the first dose of study treatment) * Male partner sterilization (vasectomy) of male partner(s) of the female participant at least six months prior to screening). The vasectomized male partner should be sole partner for that participant and received medical assessment of the surgical success. * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen. In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Women are considered not of child-bearing potential if they are post-menopausal or permanently sterileor have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to first dose of study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential. If local regulations are more stringent than the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

Interventions: DRUG: Remibrutinib, DRUG: Placebo

Conditions: Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)

Keywords: Remibrutinib, LOU064, Chronic urticaria, CINDU, CSU, Symptomatic dermographism, Cold urticaria, Cholinergic urticaria, Heat urticaria, Solar urticaria, Delayed pressure urticaria, Aquagenic urticaria, Contact urticaria

I'm interested

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 85 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06736574

Show full eligibility criteria

Inclusion Criteria:

Adult patients who meet all the following criteria at screening may be included in the study: * Are between ≥ 18 years and ≤ 85 years at the signing of informed consent * Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening * Are receiving oral loop diuretics on a regular schedule * Patients without AFF on screening ECG: * LVEF \< 30% within 6 months of screening * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL) * Patients with AFF on screening ECG: * LVEF \< 25% within 6 months of screening * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL) * Not currently taking digoxin * Meet one of the following criteria for a recent HF event: * Are currently hospitalized with the primary reason of HF * Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or * Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic. * Are established on regional standard-of-care HF therapies for at least 30 days prior to screening * Systolic blood pressure ≤ 140 mmHg

Exclusion Criteria:

Any of the following criteria will exclude potential patients from the study: * Have AFF on the screening ECG and are currently taking digoxin * Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and/or any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening * Are admitted to a long-term care facility or hospice * Have a projected survival of \< 12 months due to non-cardiovascular causes based on clinical judgment * Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening * Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening * Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure) * Have an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 or receiving dialysis at screening * Have previously had a solid organ transplant * Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening * Have received omecamtiv mecarbil in a previous clinical trial * Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP * Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease

Interventions: DRUG: Omecamtiv Mecarbil (OM), DRUG: Placebo

Conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction

Keywords: CK-1827452, omecamtiv mecarbil

I'm interested

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06203600

Show full eligibility criteria

Inclusion Criteria:

* Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma * Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen * Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma * Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form * Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration * Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle * Participants must not have received more than one prior line of systemic therapy defined as chemotherapy plus either nivolumab, pembrolizumab, or any other PD-1 or PD-L1 inhibitor, in the stage IV or unresectable setting. Peri-operative or adjuvant nivoluamb or other PD-1/PD-L1 inhibitors would count as one prior line of systemic therapy if patients progressed while on nivolumab (or other PD-1/PD-L1 inhibitors) or within 6 months of stopping it * Note: Radiation or any other regional therapy options done to address local residual disease or metastatic disease would not count as a line of therapy. Maintenance therapy with a different form of fluoropyrimidine (i.e. switching from capecitabine to fluorouracil \[5FU\]) would not count as another line of therapy * Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration * Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible * Participants must not have received a live attenuated vaccination within 28 days prior to registration * Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration * Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded * Participants must not have plans to undergo elective or planned major surgery during the clinical trial * Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration * Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study * Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy * Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements * Participants must be ≥ 18 years old * Participants must have Zubrod Performance Status of 0-2 * Participants must have a complete medical history and physical exam within 28 days prior to registration * Leukocytes ≥ 2 x 10\^3/uL (within 28 days prior to registration) * Absolute neutrophil count ≥ 1.2 x 10\^3/uL (within 28 days prior to registration) * Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration) * Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN) * Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration * Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study * Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better * Participants must have recovered to baseline or \< grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy * Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration * Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to registration, if indicated * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed * Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, DRUG: Paclitaxel, OTHER: Questionnaire Administration, BIOLOGICAL: Ramucirumab

Conditions: Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Unresectable Esophageal Adenocarcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma

I'm interested

A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06934226

Show full eligibility criteria

Interventions: DRUG: JNJ-77242113, DRUG: Matching Placebo to JNJ-77242113, DRUG: Ustekinumab, DRUG: Matching Placebo to Ustekinumab

Conditions: Plaque Psoriasis

I'm interested

Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study (KATALYST-AV)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 50 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07001800

Show full eligibility criteria

Interventions: DRUG: Ataciguat, DRUG: Placebo

Conditions: Moderate Aortic Valve Stenosis

Keywords: Ataciguat, sGC activator, sGC stimulator, Aortic valve stenosis, Moderate aortic valve stenosis, Calcific aortic valve stenosis, CAVS, Moderate Calcific Aortic Valve Stenosis, Aortic Stenosis (AS)

I'm interested

Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation (COMPANION AI)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 21 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06056271

Show full eligibility criteria

Interventions: DEVICE: AF Ablation

Conditions: Atrial Fibrillation

I'm interested

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB (ACTION3)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years to 80 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05183646

Show full eligibility criteria

DOUBLE BLIND PERIOD

Inclusion Criteria:

• Patients must be 12 to 80 years old
• A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy within 7 years of screening
• Must be either receiving an ARB at the maximal tolerated dose or willing to transition
• If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stabilization
• If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and during Stabilization
• Urine PCR \>1.5 g/g (\>169.5 mg/mmol) or 24-hour total protein \>1.5 g/day based on 24-hour urine collection during Screening.
• Estimated eGFR ≥25 and ≤120 mL/min/1.73 m2 at Screening for adults \& eGFR ≥25mL/min/1.73 m2 for adolescent patients (\<18 years)
• Seated blood pressure ≤160/100 mm Hg (mean of 3 values) (patients ≥18 years of age) or between the 5th and 95th percentile for age, sex, and height (patients \<18 years of age) at Screening
• Body weight ≥35 kg (all patients) AND a body mass index (BMI) ≤40 kg/m2 (patients ≥18 years of age) or between the 5th and 98th percentile for age and sex (patients \<18 years of age) at Screening.
• A female patient is eligible to participate if she is not pregnant or planning to become pregnant during the study, not breastfeeding, and at least one of the following conditions applies:
• Is not of childbearing potential
• If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.
• A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception
• A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent.

Exclusion Criteria:

• Has FSGS secondary to another condition.
• Patients with nephrotic syndrome (\>3.5 g/day proteinuria and serum albumin \<30 g/L) who have not previously been treated with standard of care FSGS-directed therapies (including steroids).
• History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin \[HbA1c\] \>8% at Screening)
• History of lymphoma, leukemia, or any active malignancy within the past 2 years (except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected and with no evidence of metastatic disease).
• Active clinically significant hepatobiliary disease.
• Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
• Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study.
• The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening.
• Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant.
• Positive screening assessment for viral hepatitis B surface antigen, or anti-hepatitis C virus (HCV) antibody AND positive HCV RNA, or human immunodeficiency virus 1 and 2.
• Serum potassium levels \>5.5 mmol/L at Screening.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 × upper limit of normal (ULN) at Screening.
• Treatment with non-steroid immunosuppressant agents including biological drugs (e.g. rituximab), calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening.
• History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the IP.
• Unable to swallow oral medication.
• Prior participation in any Dimerix-sponsored DMX-200 clinical study.
• Participation in a clinical study with an investigational product (IP) within 28 days or 5 half-lives (whichever is longer) prior to Screening or plans to participate in another study during the course of this study.
• Are study site personnel directly affiliated with this study and their immediate families OLE PERIOD

Inclusion Criteria:

• A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent.
• Patients who have completed participation in the double-blind period, including the Week 104 visit, and who may derive benefit from (continued) treatment with DMX-200, and/or continued follow-up
• The patient received blinded Investigational Product throughout the duration of the double-blind period up to the Week 104 visit
• The patient continues to meet the contraceptive requirements

Exclusion Criteria:

• The patient has met the criteria for permanent IP discontinuation or study discontinuation
• Any safety concerns identified during the double-blind period which, in the Investigator's opinion, may interfere with the patient's continued participation during the OLE period.

Interventions: DRUG: DMX-200, DRUG: Placebo

Conditions: FSGS

Keywords: fsgs, focal segmental glomerulosclerosis, kidney disease

I'm interested

Visualizing Brain Proteinopathies Using [F-18]Flornaptitril-PET in the Prediction of Clinical Progression of Mild Cognitive Impairment With Either Suspected Chronic Traumatic Encephalopathy or Alzheimer's Disease

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 45 years and over

Phase: PHASE3

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06254469

Show full eligibility criteria

Inclusion Criteria:

Participants with MCI enrolling in the trial must meet all the following criteria:
• Diagnosis of MCI due to suspected CTE, and with age \>45 years, or AD, and with age \>50 years at the time of the Screening Visit (see Inclusion Criteria 9) 2. Participants must have a trial partner who has frequent interaction with them (approximately \>3-4 times per week), will be present for all clinic visits, and can assist in compliance with trial procedures 3. Participants, or in the Investigator's opinion, participant's legally acceptable representative, and a trial partner provide informed consent as required by IRB 4. Female participants must be either surgically sterilized or post-menopausal, defined as at least 1 year without menses as reported by the participant or have a negative serum pregnancy test 5. Willing to comply with trial procedures 6. Willing to communicate with trial personnel 7. Willing to undergo longitudinal follow-up visits at 1 and 2 years after the Imaging Visit (only for Part B) 8. CDR global score of 0.5 9. Participants with MCI due to suspected CTE must meet the diagnostic standards of possible traumatic encephalopathy syndrome as all the following criteria: a. All of the following features are required: i) Persistence of symptoms for longer than 2 years; no other neurologic disorder that is more likely to account for all the clinical features; history of head trauma exposure, progressive course; and at least 1 supportive feature ii) History of head trauma exposure, typically associated with history of concussion, although may be limited to subconcussive trauma iii) Head trauma exposure is repetitive in nature iv) Demonstrated progressive course v) Delayed symptom onset vi) Self-report or observer report of cognitive dysfunction, confirmed with objective cognitive decline documented by results of formal neuropsychological testing. Cognitive decline typically affects more than 1 domain (neuropsychological tests, visuospatial, memory, and language) b. Only 1 of the following supportive features is required: i) Emotional dysregulation: including depression, anxiety, agitation, aggression, paranoid ideation, deterioration of interpersonal relationships, or suicidality ii) Behavioral change: including violence, poor impulse control, socially inappropriate behavior, avolition, apathy, change in personality, or comorbid substance abuse iii) Motor disturbance: including bradykinesia, tremor, rigidity, gait instability, dysarthria, dysphagia, or ataxia 9. Participants with MCI due to suspected AD must meet all the following criteria:
• Diagnosis of MCI due to suspected AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)
• Documented evidence of memory decline with gradual onset and slow progression for at least 1 year. If medically documented evidence is not available, an informant may provide confirmatory evidence
• An MMSE-2 score of 22 to 30, inclusive, at the Screening Visit
• Biomarker positive based on predefined plasma p-tau cutoff
• Modified Hachinski Ischemic Score of ˂4 at the Screening Visit
• Cognitive deficits do not occur exclusively in the context of delirium
• Cognitive deficits are not better explained by another mental disorder (e.g., major depressive disorder, schizophrenia), or other medical condition (e.g., hypothyroidism)
• Treated with a stable dosage regimen of acetylcholinesterase inhibitors (AchEI) and/or memantine for at least 4 months prior to the Screening Visit. Participants should be expected to remain on a stable dosage regimen of these medications for the duration of the trial. Participants who are not being treated with AchEI and/or memantine at the time of the Screening Visit due to contraindications or previous failed treatment with these medications are also eligible for inclusion, if it is expected that participants will not be treated with these medications for the duration of the trial. Inclusion Criteria for Healthy Volunteers (Part A):
• Medically healthy, at the age within 3 years of any participants with MCI due to suspected CTE or AD in Part A, and with no clinically relevant findings on physical examination or laboratory results
• Participants must have a trial partner who has frequent interaction with them (approximately \>3-4 times per week), will be present for all clinic visits, and can assist in compliance with trial procedures
• No cognitive impairment based upon cognitive assessment and as evaluated by the Investigator
• No first-degree family history of early-onset AD or other neurodegenerative diseases (prior to age 65)
• An MMSE-2 score ≥27.

Exclusion Criteria:

• Pregnant or breastfeeding
• Unable to remain still for duration of imaging procedure or have an inability to tolerate neuropsychological, clinical, or PET scan studies (e.g., head tremor that may cause head motion artifact, uncontrollable psychosis, acute suicidality)
• History of stroke, transient ischemic attack, seizures, or other condition of the head or neck within 12 months prior to the Screening Visit that, in the Investigator's opinion, might affect circulation to the head or image interpretation
• Preexisting major neurologic or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer)
• Psychiatric disorder such as mania, schizophrenia, anxiety, or depression (Geriatric Depression Scale ≥10), which in the Investigator's opinion, might interfere with completing trial procedures
• Condition or personal circumstance that, in the Investigator's opinion, might interfere with the collection of complete, good quality data
• History of significant prescription drug, non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin, or derivatives
• Previously received F-18 FNT at any time, or any other investigational product (IP) within the past 30 days
• History of allergic reactions to albumin, or severe anemia or cardiac failure in which case the use of albumin would be medically contraindicated
• Unstable cardiac disease or uncontrolled hypertension (systolic blood pressure \[BP\] \>170 mmHg or diastolic BP \>100 mmHg)
• Any use of benzodiazepines within 24 hours prior to all trial visits
• Plan to take ibuprofen or naproxen within 5 days before the PET scan
• Received any radioactive drugs or scans within the previous month or 10 half-lives of the drug, whichever is longer, or participated in imaging or other clinical research studies that might confound trial results
• Implants (e.g., implanted cardiac pacemakers or defibrillators, insulin pumps, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips, or other medical implants that have not been certified for MRI), a history of claustrophobia in MRI, or any contraindication for MRI
• History of any CT/MRI finding such as mass lesions or brain infection that are unrelated to the trial
• Participated in another clinical trial for an investigational agent (other than monoclonal antibody) and taken at least one dose of trial drug, unless confirmed as placebo, within 90 days prior to the Screening Visit. The end of a previous investigational trial is defined as the date of the last dose of trial drug
• Monoclonal antibody treatment within the previous 180 days prior to the Screening Visit
• Plan to receive treatment of aducanumab, lecanemab, or other potentially approved treatment options for Early AD during the trial.

Interventions: DRUG: [F-18]Flornaptitril

Conditions: Alzheimer Disease, Chronic Traumatic Encephalopathy

I'm interested

Autonomic Neural Blockade in Bariatric Surgery

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 90 years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07104825

Show full eligibility criteria

Interventions: PROCEDURE: Intraoperative autonomic neural blockade (ANB), PROCEDURE: Laparoscopic Standard of Care Abdominal Wall Block

Conditions: Bariatric Surgery Candidate, Pain, Postoperative, Nausea and Vomiting, Postoperative, Opioid Use

Keywords: Autonomic, blockade, bariatric surgery

I'm interested

Total Shoulder Arthroplasty Multi-Center Registry

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 100 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03511586

Show full eligibility criteria

Conditions: Shoulder Arthroplasty

I'm interested

A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata (ALLEGRO-100)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06873945

Show full eligibility criteria

Inclusion Criteria:

Age:
• 18 years of age or older at screening. Adolescents (12 to \<18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled. In Part 2 of the study, only adolescents (12 to \<18 years of age at both Screening and Day 1) who did not participate in Part 1 will be enrolled. Disease Characteristics:
• Must meet the following alopecia areata criteria at both Screening and Baseline:
• Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
• ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
• Current episode of hair loss ≤10 years.

Exclusion Criteria:

Medical Conditions:
• Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss.
• History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
• Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
• General Infection History: * Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1. * Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves. * Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
• Specific Viral Infection History: * History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster. * Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.
• Other Medical Conditions: * Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive. * Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening. * Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. * Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. * Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery.
• Adolescent participants 12 to \<18 years of age without one of the following: * Documented evidence from a health professional of having received varicella vaccination (2 doses); or * Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening.
• Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy:
• Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines. Prior/Concurrent Clinical Study Experience:
• Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (whichever is longer) before the first dose of study intervention in this study. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study. Receipt of study intervention in Study B7981094 or other studies of ritlecitinib. Diagnostic Assessments:
• Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
• Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities. Other

Exclusion Criteria:

• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Interventions: DRUG: Ritlecitinib 100 mg, DRUG: Ritlecitinib 50 mg, DRUG: Placebo - 100 mg, DRUG: Placebo - 50 mg

Conditions: Alopecia Areata

Keywords: alopecia universalis, alopecia totalis, alopecia, patchy hair loss, diffuse hair loss, ophiasis, hair disease, Ritlecitinib, Litfulo, hair loss, adolescents, adults

I'm interested

Alleviant ALLAY-HFrEF Study

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06812533

Show full eligibility criteria

Interventions: DEVICE: Alleviant ALV1 System, OTHER: Sham-Control

Conditions: Heart Failure

I'm interested

Pivotal Study for the Cardiac Performance System (CPS)

Contact(s):

Principal Investigator - clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase:

Healthy Volunteers:

System ID: NCT06870591

Show full eligibility criteria

Interventions: DEVICE: Cardiac Performance System (CPS)

Conditions: Cardiovascular Diseases

Keywords: Cardiac Performance System, CPS, Hemodynamic Parameters, Right Heart Catheterization

I'm interested

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06337318

Show full eligibility criteria

Inclusion Criteria:

* Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory. * NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per local pathology. Lymphoma fluorescence in situ hybridization (FISH) is not required. Molecular testing is not required. * Participants must not have follicular lymphoma with "blastoid" or "large centrocyte" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B) * Participants must have low-tumor burden follicular lymphoma defined as: * Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter * Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm. * Absence of B symptoms which may include unexplained fever, drenching sweats, unintentional weight loss (more than 10% of body weight) * No symptomatic splenomegaly * No compression syndrome (ureteral, orbital, gastrointestinal) * No pleural or peritoneal serous effusion related to follicular lymphoma Participants must have Ann Arbor stage II, III, or IV follicular lymphoma. Participants with stage I disease may be included if they do not wish to undergo radiation or are not candidates for radiation * Participants must either be experiencing distress due to their disease or would prefer active management of their disease rather than a watch and wait approach * Participants must have staging imaging performed within 49 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the chest, abdomen, and pelvis, along with a bone marrow biopsy, are acceptable. If CT scans are used for staging at baseline, a CT scan of the neck is recommended. All measurable dominant lesions must be assessed within 49 days prior to registration. Tests to assess non-measurable disease must be performed within 49 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. * NOTE: if the initial evaluation is insufficient to detect measurable disease, treating investigators may obtain a CT scan with contrast * Participants must have bi-dimensionally measurable disease (at least one lesion with longest diameter \> 1.5 cm) * Participants must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed * Participant must be ≥ 18 years of age at the time of registration * Participant must have Zubrod performance status of 0-2 * Participant must have a complete medical history and physical exam within 28 days prior to registration * Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration) * Hemoglobin \> 9.0 g/dL (within 28 days prior to registration) * Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration) * Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration) * Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) * Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been collected and processed within 28 days prior to registration * Participants must not have an active or uncontrolled infection before initiation of study treatment in the opinion of the treating investigators * Participants must not have uncontrolled diabetes within 14 days prior to registration in the opinion of the treating investigators * Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration in the opinion of the treating investigators * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated. Participants with a positive total hepatitis (Hep) B core antibody and negative hepatitis B virus surface antigen (HBsAg) at screening are at high risk for reactivation and should receive prophylactic antivirals (e.g., entecavir) before and throughout the treatment * Participants must not have autoimmune disease requiring systemic immunosuppressive therapy * Participants must not have had undergone organ transplants requiring ongoing systemic immunosuppressive therapy * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated * Participants must not have known chronic active Epstein Barr Virus infection (CAEBV); testing in asymptomatic participants is not required * Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not have a history of confirmed progressive multifocal leukoencephalopathy (PML) * Participants must not have received allogeneic stem cell transplantation * Participants must not have a history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH) * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Participant must not have significant cardiovascular disease such as class III or IV cardiac disease, myocardial infarction within 6 months prior to registration. Participants with unstable arrhythmias, or unstable angina, should be excluded * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants registered by participating United States (U.S.) sites must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, BIOLOGICAL: Mosunetuzumab, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Rituximab, BIOLOGICAL: Rituximab and Hyaluronidase Human

Conditions: Classic Follicular Lymphoma, Follicular Lymphoma With Unusual Cytological Features

I'm interested

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04153422

Show full eligibility criteria

Inclusion Criteria:

• Patients ≥ age 18
• Patient with clinical and biopsy evidence of pure small fiber neuropathy (with or without dysautonomia) as evidenced by reduced IENFD on skin biopsy using PGP 9.5 as the immunostain. Biopsy must have been performed within 12 months of study enrollment. If biopsies were not done at CRL, they will be repeated and done at 3 sites (upper and lower thigh, lower calf), to have consistent and equivalent biopsy data with the follow up biopsy done after 6 mos of treatment
• Patients must have elevated and/or abnormal titers of autoantibodies to TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 measured by the Washington University Neuromuscular Laboratory (St Louis) within 12 mos of enrollment
• Patients must have a baseline pain score on a visual analogue scale (VAS) of Greater or equal to 4/10
• Patients must have a baseline Utah Early Neuropathy Scale (UENS) score of Greater or equal to 4/10
• Small Fiber Neuropathy Screening List (SFNSL) score of 11/84 or greater
• Non-pregnant, non-lactating female. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during treatment

Exclusion Criteria:

• Any other known cause for small fiber neuropathy other than the presence of the elevated titers of TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 autoantibodies
• Patients with generalized, severe musculoskeletal conditions other than SFN that prevent a sufficient assessment of the patient by the physician
• Electromyography/nerve conduction study (EMG/NCS) evidence of large fiber polyneuropathy, to be confirmed by study PI
• Underlying severe heart, kidney, liver disease, or HIV infection, (Note: If there is no previous HIV test result documented within the last 5 years, a test may be performed in order to confirm eligibility)
• Patients with a history of deep vein thrombosis within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or deep vein thrombosis
• Known significant IgA deficiency with antibodies to IgA
• History of hypersensitivity, anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of IVIG 10%
• Known blood hyperviscosity, or other hypercoagulable states
• Use of IgG products within six months prior to enrollment
• Patients with a history of drug or alcohol abuse within the past five years prior to enrollment
• Patients unable to understand or unwilling or unable to comply with the study protocol

Interventions: DRUG: Panzyga IVIG, DRUG: Placebo

Conditions: Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy, Inflammatory Polyneuropathy, Immune-Mediated Neuropathy

Keywords: Small Fiber Neuropathy, Neuropathy, Intravenous Immunoglobulin, IVIG, TS-HDS antibody, FGFR-3 antibody, FGFR3 antibody, Immune mediated small fiber neuropathy, Panzyga, Plexin D1 antibody

I'm interested

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (RIVER-AD)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05492578

Show full eligibility criteria

Inclusion Criteria:

* Participant must be at least 12 years of age inclusive at the time of signing the informed consent. * Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. * Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600 * Participants in DRI17366 must only be enrolled from 1 of the following 3 groups: * The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2. * The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52. * The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up. * Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit * Complied with the previous clinical trial protocol to the satisfaction of the investigator * Body weight must be ≥25 kg * Provided signed informed assent/or consent and able to comply with the requirements of the protocol

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply: * Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol * Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration * History of solid organ or stem cell transplant * Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline) * Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test * History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator * Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening * Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:
• Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
• Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
• For whom review and approval from Sponsor have been granted are eligible * Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease * Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment * Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments * In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions: DRUG: Amlitelimab, DRUG: Topical corticosteroids, DRUG: Topical calcineurin inhibitors, DRUG: Oral corticosteroids

Conditions: Dermatitis Atopic

I'm interested

Improving Safety, Patient Experience and Equity Through Shared Decision-making Huddles in Labor (I'M SPEAKING)

Contact(s):

clinicaltrials@northshore.org

Sex: FEMALE

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06828406

Show full eligibility criteria

Interventions: BEHAVIORAL: TeamBirth

Conditions: Perinatal Decision Making

Keywords: Shared Decision Making, Quality Improvement, Cesarean Birth, Labor and Delivery, Nulliparous Term Singleton Vertex, Illinois Perinatal Quality Collaborative, Promoting Vaginal Birth, Birth Equity, Severe Maternal Morbidity

I'm interested

A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines (RECLAIM)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06868212

Show full eligibility criteria

Inclusion Criteria:

* Adults ≥ 18 years of age at the time of signing the informed consent * CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation) * Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as: * The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1): * UAS7 score (range, 0-42) ≥ 16, and * ISS7 score (range, 0-21) ≥ 6, and * HSS7 score (range, 0-21) ≥ 6 * Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants medical history * Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol * Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)

Exclusion Criteria:

* Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors * Previous use of dupilumab * Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant. * Evidence of hematological disorders (including coagulation disorders or significant bleeding risk) * History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion) * Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited. * Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants \[NOAC\]) * History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) \> 1.5 at screening

Interventions: DRUG: Remibrutinib, DRUG: Remibrutinib matching placebo, DRUG: Dupilumab, DRUG: Placebo solution for injection

Conditions: Chronic Spontaneous Urticaria (CSU)

Keywords: BTK inhibitor, chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score

I'm interested

An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 65 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06927999

Show full eligibility criteria

Inclusion Criteria:

* Is a male or female between the ages of 18 and 65 years, inclusive. * Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment. * Has been on a daily chronic treatment for ≥ 6 weeks. * Is willing to use a smartphone study application to record study assessments and AEs. * Has body weight more than 15 kilogram (kg). * Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years * If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline. * Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application. * Is willing and able to provide written informed consent prior to participating in the study. * Controlled hypertension without beta blocker confirmed by the Investigator is acceptable. * At screening, has stable vital signs in the following ranges (after 5 minutes of rest): * Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg) * Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg * Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)

Exclusion Criteria:

* Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. * Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator. * Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG) * Has had significant traumatic injury or major surgery within 30 days prior to study screening. * Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules). * Has participated in a clinical trial within 30 days prior to the first dose of study drug. * Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.

Interventions: DRUG: Placebo, DRUG: 0.5 mg epinephrine, DRUG: 1 mg epinephrine

Conditions: Urticaria Chronic

I'm interested

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis (CLEOPATTRA)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07207811

Show full eligibility criteria

Inclusion Criteria:

• Male or female.
• Age 18 years or above at the time of signing the informed consent.
• Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. Note: Target ATTRv recruitment is approximately 15 percent of the study population. a. Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) nuclear medicine imaging with single-photon emission computed tomography (SPECT) or SPECT/CT (preferably) combined with an extracardiac biopsy positive for TTR amyloid, OR iii. Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP nuclear medicine imaging with SPECT or SPECT/CT (preferably) combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE)/or mass spectrometry based methods including mass fixation). Notes: * Non-invasive diagnostic pathway will be confirmed by a centralised expert review. * Bone tracer nuclear medicine imaging with SPECT or SPECT/CT (preferably) will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP), 99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD), or 99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP). * The eGFR adjusted acceptable serum free light chain ratio. * Patients with Grade 2 or 3 cardiac uptake at PYP/DPD/HDMP nuclear imaging with SPECT or SPECT/CT (preferably) and evidence of monoclonal gammopathy of undetermined significance (MGUS; based on serum and urine protein electrophoresis and serum free light chains) will require endomyocardial biopsy with typing using mass spectrometry or immunohistochemistry to confirm presence of TTR protein in tissue. * Timing of serum free light chain ratio, SPIE, UPIE and mass spectrometry-based methods including mass fixation should be within 12 months of SPECT or SPECT/CT nuclear imaging. b. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm). c. Chronic HF (New York Heart Association \[NYHA\] Class I-IV): i. At least 1 documented hospitalisation for HF, OR ii. History of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary congestion on x-ray or auscultation, or peripheral oedema that required or requires ongoing treatment with a diuretic).
• Expected to be on stable cardiovascular medical therapy (defined as no greater than 50 percent dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.
• Completed more than 50 meters on the 6MWT at screening.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.
• Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening.
• Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma.
• HF not primarily caused by ATTR-CM (e.g., due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator).
• Currently hospitalised or hospitalised within 14 days prior to screening.
• Currently treated with positive inotropic medication.
• Uncorrected, severe, haemodynamically significant, left-sided heart valve disease.
• Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 60 days of screening.
• Prior solid organ transplant or planned solid organ transplant during the study.
• Left ventricular ejection fraction (LVEF) less than 30 percent as assessed by centralised review of echocardiography.
• Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, carcinoma in situ/high-grade prostatic intraepithelial neoplasia \[PIN\], low-risk prostate cancer, or on stable therapy for prostate cancer) within 3 years before screening.
• End-stage renal disease (estimated glomerular filtration rate \[eGFR\] less than 15 mL/min/1.73 m\^2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).

Interventions: DRUG: NNC6019-0001, DRUG: Placebo (NNC6019-0001)

Conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM)

I'm interested

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06126276

Show full eligibility criteria

Inclusion Criteria:

* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191 * Patients must have a HER2 amplified solid tumor except breast cancer. * If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status * If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status * If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE * If IHC is unknown and… * ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE * ISH/FISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE * Patients must have recurrent or persistent disease * No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation * Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191) * Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required * Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic * No known leptomeningeal disease * Patients may have received up to 5 prior lines of systemic therapy * Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed * No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib * No prior therapy with CDK4/6 inhibition * No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration * Age ≥ 18 * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 * Not pregnant and not nursing * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable) * Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula * Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN) * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * No active infection requiring parenteral antibiotics * No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube * No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy * No lung disease causing dyspnea at rest * No interstitial lung disease with ongoing signs and symptoms at the time of registration * No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients

Interventions: PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, DRUG: Neratinib Maleate, DRUG: Palbociclib

Conditions: Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm

I'm interested

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

Contact(s):

clinicaltrials@northshore.org

Sex: MALE

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05946213

Show full eligibility criteria

Inclusion Criteria:

* Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer * High-risk disease defined as having at least one or more of the following: * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) Note: cT4 by imaging or on digital rectal exam is not allowed * The patient's prostate specific antigen (PSA) value \> 20 ng/mL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors * Gleason Score of 8-10 * Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm * Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan * No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 * No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * No prior radical prostatectomy * No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \[HIFU\], laser ablation, cryotherapy, irreversible electroporation \[IRE\], and vascular-targeted photodynamic therapy) * Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \[LHRH\] agonist and oral anti-androgen) is =\< 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease * No contraindication to prostate MRI (required for planning of radiotherapy in both arms) * Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, RADIATION: External Beam Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Stereotactic Body Radiation Therapy

Conditions: Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

I'm interested

Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

Contact(s):

clinicaltrials@northshore.org

Sex: FEMALE

Age: 22 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06556654

Show full eligibility criteria

Inclusion Criteria:

• Female subjects ≥ 22 years of age.
• First-time breast reconstruction post-mastectomy for target breast(s).
• Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy.
• Mastectomy performed to address breast cancer or for cancer prophylaxis.
• An informed consent form is signed by Subject or Legally Authorized Representative (LAR).
• Subject is capable of following protocol procedures and complying with follow-up visit requirements

Exclusion Criteria:

Baseline Exclusion Criteria
• Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction.
• Subject has undergone previous radiation therapy to the reconstruction site or chest wall.
• Subject has had chemotherapy within 3 weeks prior to the index procedure.
• Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure.
• Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA).
• Subject has a BMI \> 35.
• Subject has a known diagnosis of diabetes with a HbA1c \> 7.0mmol/L within 30 days of the Index procedure (i.e., TE placement).
• Subject was a current or former tobacco/nicotine user, within 90 days prior to Index Surgery (i.e., TE placement).
• Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction.
• Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
• Subject is currently participating in or planning to participate in another investigational drug, biologic or medical device study that may interfere with compliance of TBR 22-07 study requirements or may confound TBR 22-07 study data/outcomes.
• Subject requires a surgical technique requiring flap (autologous tissue).
• Subject is pregnant or lactating at the time of the index procedure (i.e., TE placement) or is planning to become pregnant prior to the Exchange procedure. Intraoperative Index Procedure Exclusion
• Based on investigator's opinion, subject has unsuitable tissue integrity for immediate 2-stage breast reconstruction or is no longer a candidate to receive the TRBR Device (will be recorded as a screen failure).
• Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)

Interventions: DEVICE: TRBR Device

Conditions: Breast Reconstruction Surgery

Keywords: breast reconstruction, post-mastectomy, tissue expander, implant based breast reconstruction, two-stage, immediate, subpectoral, prepectoral

I'm interested

Prevail Global Study

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06535854

Show full eligibility criteria

Interventions: DEVICE: Prevail DCB, DEVICE: Agent DCB

Conditions: Coronary Artery Disease

Keywords: ISR, DNSV

I'm interested

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (VITALIZE)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06290141

Show full eligibility criteria

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 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee. * Participants must have responded to IVIg in the past 5 years. * Participant must be on a stable maintenance dosage of IVIg. * Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT). * Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines. * Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline. * 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 * Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive. * Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.

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 IgM monoclonal gammopathy, POEMS syndrome, 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, 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 contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening). * Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the 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 the 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 the 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. * Recent treatment with plasma exchange * Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive/ chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine). * Prior treatment with riliprubart. * Recent use of any specific complement system inhibitor (eg, eculizumab). * 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. * 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; imprisoned or legally institutionalized. * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. * Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol. * Recent treatment with efgartigimod. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Interventions: DRUG: riliprubart, DRUG: Placebo, DRUG: riliprubart, DRUG: Placebo, DRUG: IVIg, DRUG: Placebo

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

I'm interested

Search Results

RECOVER-SLEEP: Platform Protocol

Paired-Ring Mitral Annuloplasty Ring Sizing Device

A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM (SNAPSHOT- PKP2)

Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC) (NEC)

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND)

Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study (KATALYST-AV)

Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation (COMPANION AI)

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB (ACTION3)

Visualizing Brain Proteinopathies Using [F-18]Flornaptitril-PET in the Prediction of Clinical Progression of Mild Cognitive Impairment With Either Suspected Chronic Traumatic Encephalopathy or Alzheimer's Disease

Autonomic Neural Blockade in Bariatric Surgery

Total Shoulder Arthroplasty Multi-Center Registry

A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata (ALLEGRO-100)

Alleviant ALLAY-HFrEF Study

Pivotal Study for the Cardiac Performance System (CPS)

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (RIVER-AD)

Improving Safety, Patient Experience and Equity Through Shared Decision-making Huddles in Labor (I'M SPEAKING)

A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines (RECLAIM)

An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis (CLEOPATTRA)

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

Prevail Global Study

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (VITALIZE)

Email this study information to me

Contact the study team