Search Results
227results
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
clinicaltrials@northshore.org
ALL
18 years to 99 years old
PHASE3
NCT07575399
Inclusion Criteria:
* Body Mass Index (BMI) ≥ 25 at screening.
* Weight loss of ≥ 10% on weekly GLP-1 RA.
* Stable body weight.
* Stable dose of GLP-1RA.
* Stable gastrointestinal (GI) tolerability.
* Contraception for females.
* Willingness to follow trial procedures for the duration of the trial.
Exclusion Criteria:
* Obesity induced by other endocrine disorders (ex: Cushing's syndrome).
* Previous or planned surgical, endoscopic or device-based treatment for obesity.
* History of malignancy.
* Type 1/Type 2 diabetes mellitus (DM).
* Family or personal history of medullary thyroid cancer.
* Previous participation in a Maridebart Cafraglutide trial. DRUG: Maridebart Cafraglutide
Obesity or Overweight
Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer
clinicaltrials@northshore.org
ALL
12 years and over
PHASE3
NCT07215910
Inclusion Criteria:
* STEP 0: Histologic diagnosis of astrocytoma, IDH-mutant (central nervous system \[CNS\] WHO grade 3)
* STEP 0: Available diagnostic slides (hematoxylin and eosin staining method \[H\&E\] and immunohistochemical stains for central review)
* STEP 0: Tissue available for central biomarker testing (CDKN2A/B and1p/19q co-deletion \[all patients\], and IDH1/IDH2 \[if needed\])
* STEP 1: Centrally-confirmed diagnosis of astrocytoma, IDH-mutant (CNS WHO grade 3)
* STEP 1: Presence of IDH1 p.R132 or IDH2 p.172 mutation, confirmed by central review of immunohistochemical stain or molecular testing results, with central confirmation of equivocal results
* STEP 1: Absence of CDKN2A/B homozygous deletion by central testing
* STEP 1: Absence of whole arm 1p/19q co-deletion (i.e. intact 1p/19q) by central testing
* STEP 1: No evidence of spinal or leptomeningeal disease
* STEP 1: No prior chemotherapy, cranial irradiation, IDH-inhibitor therapy, radiotherapy, vaccine therapy, small-molecule therapy, or laser ablation
* STEP 1: Prior diagnostic surgery/resection/biopsy ≤ 6 months of registration
* STEP 1: Planned radiotherapy and adjuvant chemotherapy
* STEP 1: Age ≥ 12 years
* STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky performance status \[KPS\] ≥ 60%)
* STEP 1: Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* STEP 1: Hemoglobin ≥ 9 g/dL
* STEP 1: Platelet count ≥ 100,000/mm\^3
* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
\* For patients with Gilbert syndrome, total bilirubin ≤ 1.0 x ULN
* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x ULN
* STEP 1: Alkaline phosphatase ≤ 2.5 x ULN
* STEP 1: Creatinine ≤ 2.0 x ULN or calculated (calc.) creatinine clearance \> 40 mL/min
\* For patients ≥ 18 years of age, calculated using the Cockcroft-Gault equation. For patients \< 18 years of age, calculated using the Bedside Schwartz method:
* Age: 10 to \< 13 years; Maximum Serum Creatinine (mg/dL): 1.2 (male) 1.2 (female)
* Age: 13 to \< 16 years; Maximum Serum Creatinine (mg/dL): 1.5 (male) 1.4 (female)
* Age: ≥ 16 years; Maximum Serum Creatinine (mg/dL): 1.7(male) 1.4 (female)
* STEP 1: Not pregnant and not nursing, because this study involves agents whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown
\* Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required
* STEP 1: Women and men of reproductive potential should agree to abstain from sexual intercourse or use two highly effective methods of birth control, at least one of which must be a barrier method, throughout their participation in this study and for at least 90 days after the last dose of vorasidenib. Reproductive status and discussions about birth control measures should be documented in the patient's record. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of birth control. Highly effective forms of birth control are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, intrauterine hormone release systems, bilateral tubal ligation, condoms with spermicide, or male partner sterilization
* STEP 1: No severe or intercurrent illness, no active infection that requires systemic anti-infective therapy, and no active infection with an unexplained fever \> 38.5°C within 7 days prior to registration
* STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* STEP 1: Patients must be able to tolerate or undergo an MRI
* STEP 1: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* STEP 1: No significant active cardiac disease within 6 months prior to registration, including New York Heart Association Functional Classification class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke. To be eligible for this trial, patients should be class 2B or better
* STEP 1: No history of significant (grade ≥ 2) intratumoral or peri-tumoral hemorrhage
* STEP 1: No known active inflammatory gastrointestinal disease, chronic diarrhea, prior gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition causing an inability to swallow oral formulations of agents. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential)
* STEP 1: No known hypersensitivity to any of the components of vorasidenib or temozolomide
* STEP 1: No other acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or protocol therapy administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
* STEP 1: No concurrent use of other investigational agents
* STEP 1: No concurrent use of alternating tumor treating field (TTField) therapy
* STEP 1: No concurrent use of therapeutic doses of steroids for glioma. Concurrent use of physiologic doses of steroids (defined as equivalent of ≤ 10 mg prednisone daily) for medical conditions unrelated to glioma is allowed. Corticosteroids administered for reasons related to glioma should be used in the smallest dose possible to control symptoms of cerebral edema and mass effect and discontinued whenever possible.
* STEP 1: No concurrent use of warfarin sodium or any other Coumadin-derivative anticoagulant. Patients must be off Coumadin-derivative anticoagulants for at least 7 days prior to registration. Low molecular weight heparin (LMWH) and factor Xa inhibitors are allowed
* STEP 1: No concurrent use of strong and moderate CYP1A2 inhibitors, moderate CYP1A2 inducers, or CYP3A substrates where a minimal concentration change can reduce efficacy. Patients should be transferred to other medications prior to registration
Exclusion Criteria:
\- RADIATION: Intensity-Modulated Radiation Therapy, RADIATION: Volume Modulated Arc Therapy, RADIATION: Pencil Beam Scanning, PROCEDURE: Intensity-Modulated Proton Therapy, DRUG: Temozolomide, DRUG: Vorasidenib, DRUG: Placebo Administration, PROCEDURE: Biospecimen Collection, PROCEDURE: Magnetic Resonance Imaging, OTHER: Questionnaire Administration
Astrocytoma, IDH-Mutant, Grade 3
E-Mindfulness Approaches for Living After Breast Cancer (HEAL-ABC)
clinicaltrials@northshore.org
ALL
18 years to 50 years old
PHASE3
NCT06748222
Inclusion Criteria:
* The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.
* The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.
* The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
* The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).
* Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)
* Participant must be able to understand, speak, read, and write in English or Spanish.
* Participant must be willing to participate in a 6-week program to receive training in mindfulness.
* Participant must be able to use a smartphone, tablet, or other digital device.
* Sex assigned at birth must be female.
Exclusion Criteria:
* Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .
* Any history or current evidence of recurrent or metastatic breast cancer.
* Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
* Currently pregnant or planning to become pregnant in the near future.
* Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities. BEHAVIORAL: Mindfulness (MAPs) Live Online, BEHAVIORAL: Mindfulness (MAPs) Digital App, BEHAVIORAL: Meditation Only Control Group
Breast Cancer, Depression
Breast Cancer, Mindfulness, Meditation, Digital
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (AVENUE)
clinicaltrials@northshore.org
ALL
12 years to 17 years old
PHASE3
NCT07227454
Inclusion Criteria:
* Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)
* Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of "Markedly" or greater (that is, greater than or equal to \[\>=\] 4) at both screening and baseline (predose) visits
* Must have a children's depression rating scale - revised (CDRS-R) total score \>= 58 at baseline (predose)
* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality
* Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Exclusion Criteria:
* Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder
* Participant currently meets DSM-5 criteria for borderline personality disorder
* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis
* Participant has a history of seizure disorder
* Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients DRUG: Esketamine, DRUG: Midazolam, OTHER: Oral Placebo, OTHER: Intranasal Placebo
Depressive Disorder, Major
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
clinicaltrials@northshore.org
MALE
18 years and over
PHASE2
NCT07005154
Inclusion Criteria:
* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
* Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.
* Participant must have an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC.
* Participant is able to understand and comply with all study requirements and procedures.
* Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).
* Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).
Note: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.
* If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:
* Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3.
* PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng/mL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment.
* If the participant has mCRPC, participant has a serum testosterone level \< 1.73 nmol/L (\< 50 ng/dL) at the Screening visit.
* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.
* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration.
* Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.
* Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.
* Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation.
Exclusion Criteria:
* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
* Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and/or radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible.
* Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following:
* Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type
* Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years
* Any other cancer from which the participant has been disease-free for ≥5 years
* Participant has clinically significant cardiac disease, defined as any of the following:
* Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.
* Congenital long QT syndrome.
* QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.
* History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \< 50% at baseline.
* Cohorts 1 and 3: Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.
* Cohort 2: Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months.
* Cohorts 1 and 3: Uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.
* Cohort 2: Uncontrolled hypertension, defined as systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1.
* Cohort 1 and 3: Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \> 1 month before Cycle 1 Day 1).
* Cohort 2: Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months.
* Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.
* Participant has had major surgery (e.g., requiring general anesthesia) within 30 days before screening, or has not fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
* Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.
* Participant received a blood transfusion within 1 month of the first dose of study intervention.
* Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
* Participant has hemoglobin A1c (HbA1c) \> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.)
* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA).
* Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).
* Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).
* Participant has a body mass index \> 40 kg/m2.
* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.
* Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.
* Participant received treatment with herbal medications with known anti-cancer properties or known effects on prostate physiology within 4 weeks prior to Cycle 1 Day 1 (e.g., saw palmetto, St. John's wort, turmeric/curcumin). Participants must agree not to use herbal products during study participation.
* Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.
* Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.
* Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg/day or less prior to first dose of study drug is eligible for study entry.
* Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.
* For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:
* Hormonal therapy (e.g., androgen receptor blockers \[AR\] antagonists, second-generation androgen receptor pathway inhibitors \[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted.
* Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)
* Biologic therapy within 4 weeks of C1D1
* Immunotherapy within 4 weeks of C1D1
* Radiation therapy (includes radioligands) within 4 weeks of C1D1
* For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
* Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.
* Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.
* Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1.
* Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1.
* Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.
* Participant has received ASP5541 previously.
* Participant has absolute neutrophil count \< 1500/μL, platelet count \< 100000/μL or hemoglobin \< 9 g/dL (6.2 mmol/L) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.
* Participant has serum total bilirubin \> 1.5 x upper limit of normal (ULN) (or \> 3 x ULN for participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \> 2.5 x ULN at Screening.
* Participant does not have adequate renal function defined as a calculated creatinine clearance \< 30 mL/min as determined by a validated algorithm for calculating creatinine clearance.
* Participant has serum albumin \< 3.0 g/dL (30 g/L) at Screening.
* Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.
* Participant has a gastrointestinal disorder affecting absorption. DRUG: ASP5541, DRUG: Prednisone, DRUG: Prednisolone, DRUG: abiraterone acetate, DRUG: Adrenocorticotropic hormone
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
ASP5541, PRL-02
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract (FORAGER-2)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07218380
Inclusion Criteria:
* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.
* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.
* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Have adequate laboratory parameters
Exclusion Criteria:
* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).
* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\[CTCAE\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.
* Have ongoing sensory or motor neuropathy of Grade 2 or higher
* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.
* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening. DRUG: Vepugratinib, OTHER: Placebo, DRUG: EV, DRUG: Pembrolizumab
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis
FGFR3, Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Aspiration Thrombectomy Using the Symphony or Prodigy System (CLEAR-IT)
clinicaltrials@northshore.org
ALL
18 years and over
NCT07350499
Inclusion Criteria:
• Subject is ≥ 18 years of age
• Subject is willing and able to comply with the follow-up schedule specified in this protocol
• Subject is willing and able to provide written informed consent prior to any study-related data collection
• Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use
Exclusion Criteria:
• Subjects with any contraindications per the applicable Instructions for Use
• Subject with life expectancy of less than 1 year
• In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
• Subject who may be unable to complete study follow-up
• Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging
DEVICE: Prodigy Thrombectomy System, DEVICE: Symphony Thrombectomy System, DEVICE: Symphony Thrombectomy System
Arterial Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
Pulmonary Embolism, Thrombus, Thromboembolism, Aspiration, Aspiration thrombectomy, Anticoagulation, Peripheral vasculature
ICU CONNECT: Study Comparing EMG in Healthy Volunteers and ICU Patients. (ICU CONNECT)
clinicaltrials@northshore.org
ALL
18 years to 90 years old
NA
NCT07699562
Inclusion Criteria:
* Cohort 1: Healthy volunteers
Inclusion criteria:
* Subjects must be \> 18 years old and \< 90 years old.
* Subjects must consent to participate. Cohort 2: Non-intubated critically ill patients
Inclusion criteria:
* Subjects may be male or female.
* Subjects must be \> 18 years old and \< 90 years old.
* Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).
Cohort 3: Intubated critically ill patients
Inclusion criteria:
* Subjects may be male or female.
* Subjects must be \> 18 years old and \< 90 years old.
* Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).
* For the Subjects in the ICU that are intubated, they must be planned to be intubated for at least 24 hours.
* Subjects must be intubated for no longer than ≥ 72 hours before enrollment.
Exclusion Criteria:
* Cohort 1: Healthy volunteers
Exclusion criteria:
* Subjects with previous paralysis or neuromuscular disease.
* Subjects with spinal cord or brain injuries that impact motor function.
* Subjects with an allergy to clinical adhesive or hydrogel. Cohort 2: Non-intubated critically ill patients
Exclusion criteria:
* Subjects with previous paralysis or neuromuscular diseases.
* Subjects with previous peripheral nerve injuries to the tested limbs.
* Subjects with spinal cord or brain injuries (including stroke) that impact motor function.
* Subjects without a POA or next of kin for those patients that are unable to consent themselves.
* Subjects with an allergy to clinical adhesive or hydrogel. Cohort 3: Intubated critically ill patients
Exclusion criteria:
* Subjects with previous paralysis or neuromuscular disease
* Subjects with previous peripheral nerve injuries to the tested limbs.
* Subjects with spinal cord or brain injuries that impact motor function.
* Subjects without a POA or next of kin for those patients that are in the intubated arm.
* Subjects with intubations expected to last less than 24 hours.
* Subjects who have already been intubated for \> 72 hours.
* Subjects with an allergy to clinical adhesive or hydrogel. DEVICE: TetraGraph, DEVICE: Electromyography, DEVICE: Nerve conduction studies
ICU Acquired Weakness
Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study (ALARION EV)
clinicaltrials@northshore.org
ALL
18 years and over
NA
NCT07324031
Inclusion Criteria:
• At least 18 years old
• Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
Exclusion Criteria:
• Patients who cannot read or write
• Expected survival \< 1 year
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
• Participation in any concurrent clinical study without prior approval from the Sponsor
• Inability or unwillingness to provide informed consent to participate in the study
• Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
• Circumstances that may prevent data collection or completion of specified follow-up visits
• Allergies to any device materials listed in the Instructions for Use (IFU)
• Contraindication for temporary suspension of oral/systemic anticoagulation
• Known history of lung disease with FEV1 \< 1.0 Liter Device Related:
• Implanted with or planned implantation of any device which delivers current in the body that may interfere with therapy delivery, including, but not limited to a pacemaker, LVAD or neurostimulator
• Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
• Any known need for MRI prior to approval of MRI conditional labeling Anatomy Related:
• Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure
• Known obstructed or restricted pathway into the mediastinum for the Atala™ lead
• Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type
• Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
• History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure
• Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
• Surgically corrected congenital heart disease (not including catheter-based procedures) Cardiac Related:
• Indication for permanent bradycardia pacing or cardiac resynchronization therapy
• Decompensated heart failure
• Currently on inotropic therapy
• Known history of pericardial disease, pericarditis or mediastinitis
• Risk factors associated with defibrillation testing: * Severe aortic stenosis * Current Intracardiac LA or LV thrombus * Severe proximal three-vessel or left main coronary artery disease without revascularization * Hemodynamic instability * Unstable angina * Recent stroke or transient ischemic attack (within the last 3 months) * Known inadequate external defibrillation * LVEF \< 20% (most recent assessment; must be within 180 days of consent) * LVEDD \>70 mm (most recent assessment; must be within 180 days of consent)
DEVICE: Atala™ lead and EV-ICD Pulse Generator
Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
Ventricular Defibrillation, Extravascular
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer
clinicaltrials@northshore.org
FEMALE
18 years to 55 years old
PHASE1
NCT07310420
Inclusion Criteria:
• Age and gender:
• Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive.
• GnRH treatment-exposed \<6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within \<6 months of signing the informed consent.
• Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment.
• HR+: Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry.
• HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines.
• Prior treatment:
• Participants may have received prior radiotherapy.
• Participants may have received or be receiving a cyclin-dependent kinase (CDK) 4/6 inhibitor, a phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha-protein kinase B (PIK3CA-AKT) inhibitor, or bisphosphonates if initiated and at a stable dose for at least 2 weeks before trial enrollment.
• GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy in the advanced/metastatic setting.
• GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy provided they had established premenopausal status prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment.
• Chemotherapy History: a. A participant may have received adjuvant or neoadjuvant chemotherapy in early-stage breast cancer. i. Any participant who received prior adjuvant or neoadjuvant chemotherapy are eligible provided the criteria for premenopausal status. b. All chemotherapy-related toxicities must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 ≤Grade 1 before trial participation, except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2).
• Concurrent Medications:
• Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \>Grade 1 for at least 2 weeks before trial enrollment.
• PIK3CA/AKT inhibitors are permitted if started at least 2 weeks before the trial and tolerated without ongoing toxicity CTCAE v6.0 \>Grade 1.
• Concomitant use of bisphosphonates is permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \>Grade 1 for at least 2 weeks before trial enrollment.
• Concomitant use of endocrine therapy (eg, aromatase inhibitor, fulvestrant, or other FDA-approved selective estrogen receptor degraders \[SERDs\]) is permitted.
• Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
• Contraceptive use: Female participants may be enrolled if they are:
• Practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, OR
• Using 2 forms of highly effective nonhormonal contraception, including 1 physical barrier (condom or diaphragm) plus another nonhormonal method (eg, intrauterine device, spermicidals) from Screening or at least 2 weeks prior to IP administration (whichever is earlier) until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1.
• Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria:
• Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
• Body mass index (BMI): \<18 kg/m\^2 or \>35.0 kg/m\^2.
• Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.
• Recent radiotherapy:
• Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.
• All radiotherapy-related toxicities (except alopecia) must have recovered to CTCAE v6.0 ≤Grade 1 before trial enrollment.
• Radiotherapy during trial: Planned radiotherapy during trial period.
• Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed.
• Hypersensitivity: Known hypersensitivity, idiosyncratic, or allergic reactions to goserelin, GnRH, GnRH agonists/analogs, or any trial drug components.
• Expected survival: Estimated life expectancy \<6 months from the start of trial therapy, based on the principal investigator's (PI) clinical judgment.
• Performance status: ECOG performance status ≥3.
• Life-threatening disease or metastasis: Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, symptomatic pulmonary lymphangitic spread, symptomatic pleural disease, or any symptomatic brain/leptomeningeal metastases (proven or suspected). Participants with asymptomatic or stable/treated brain metastases are eligible to enroll if neurologically stable and are receiving a stable or decreasing corticosteroid dose at the time of enrollment. Participants with discrete pulmonary parenchymal metastases are eligible if respiratory function is not compromised.
• Hepatic function:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2×upper limit of normal (ULN) if no liver metastases, or \>5×ULN with liver metastases.
• Total bilirubin ≥1.5×ULN (≥2.5×ULN for Gilbert's syndrome).
• Renal function: Creatinine clearance (CrCl) ≤30 mL/min as calculated by the Cockcroft-Gault formula.
• Hematologic parameters:
• Hemoglobin (Hgb) \<8.0 g/dL.
• White blood cell (WBC) count \<3000/mm\^3.
• Platelets \<100,000/mm\^3.
• Other malignancies: Active malignancy within the past 3 years, except for adequately treated basal or squamous cell skin cancer or in situ cervical carcinoma.
• Concurrent medical conditions: Presence of any severe, uncontrolled, or serious illness, medical condition (including psychiatric/addictive disorders), or clinical finding that could compromise trial adherence, as assessed by the investigator.
• Investigational drug exposure: Exposure to any investigational drug or device within 30 days prior to trial enrollment.
• Pregnancy: Participant has childbearing potential with a positive serum pregnancy test or positive urine pregnancy test at Screening or Day 1.
• Breastfeeding: Participant is currently breastfeeding.
• Contraceptive use: Sexually active with a male partner and not willing to use nonhormonal contraceptive methods throughout the trial. Exceptions: male partner is vasectomized (provided he is her sole sexual partner, and he has received medical assessment of the surgical success), participant has had bilateral salpingectomy or tubal occlusion hysterectomy.
• Cardiac conditions:
• Corrected QT interval (QTc) using Fridericia's correction (QTcF) \>450 ms at Screening.
• Uncontrolled or symptomatic heart disease, including: i. New York Heart Association (NYHA) Class III or IV heart failure. ii. Myocardial infarction within the past 6 months. iii. Unstable angina or significant arrhythmias requiring intervention. c. Documented congenital QT syndrome.
• Clinically relevant abnormal medical history or abnormal findings on physical examination, vital signs, echocardiogram (ECG), or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within the last 1 year prior to IP administration.
• Major surgery within 30 days prior to IP dosing or a major surgical procedure planned during the trial.
• Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety, as per the investigator's judgment.
DRUG: ZOLADEX
Advanced Breast Cancer
Ovarian Suppression, ZOLADEX, HR+, HER2-, Breast Cancer, Goserelin Implant
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes (Enith1)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07351045
Inclusion Criteria:
* Participants must have at screening:
• Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
• BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Exclusion Criteria:
* History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
* Poorly controlled hypertension at screening
* Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
* Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization COMBINATION_PRODUCT: Placebo, COMBINATION_PRODUCT: Enicepatide
Obesity or Overweight
Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
clinicaltrials@northshore.org
ALL
18 years and over
NCT07101094
Inclusion Criteria:
* Aged ≥18 years at index date.
* Have a confirmed diagnosis of schizophrenia before index date.
* Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.
* Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.
* Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).
* English or Spanish speaking.
Exclusion Criteria:
* Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.
* Evidence of use of XT prior to time of eligibility screening. DRUG: xanomeline and trospium chloride (X/T) therapy
Schizophrenia
Schizophrenia
Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes (CLARITY)
clinicaltrials@northshore.org
ALL
18 years to 70 years old
NCT06661850
Inclusion Criteria:
• Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
• Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
• Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
• Subject has a diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI);
• Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
• Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
• Subject has failed at least ≥ 6 months of non-operative treatment (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator;
• Subject has signed the IRB approved Informed Consent Form; and
• Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Exclusion Criteria:
• Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
• Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);
• Surgery is planned for more than 2 lumbar levels.
• Subject has severe spinal canal stenosis as assessed by the Investigator;
• Subject has a motor strength deficit(s) in lower extremities
• Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including: * Spondylolisthesis Grade 2 or greater (up to Grade 1 is accepted) * Pars fracture, at the involved level * Spondylolysis * Lumbar scoliosis with a Cobb angle of greater than 15° * Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst * Lumbar kyphosis
• Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
• Subject is contraindicated for a standard lumbar MRI exam
• Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed
• Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
• Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and/or may confound data
• Subject has a BMI \> 40
PROCEDURE: Fusion or TDR determined by investigator.
Discogenic Low Back Pain
MR Spectroscopy, MRI, back pain, Nociscan
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation (PERSIGMA RCT)
clinicaltrials@northshore.org
ALL
18 years to 80 years old
NA
NCT07523750
Inclusion criteria:
* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \[\>\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
* Participant is aged 18 - 80 years at the time of informed consent
* Participant is willing and capable of providing informed consent
* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion criteria:
* Participant has continuous AF \> 365 days (longstanding persistent AF)
* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
* Participant has had previous surgical or catheter ablation for AF
* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
* Participant has severe dilatation of the LA (LAD \> 50 millimeters \[mm\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
* Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \[\<\] 40%) confirmed by imaging performed within 180 days prior to enrollment
* Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
* Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment
* Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
* Participant has had valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
* Participant has unstable angina within past 6 months prior to enrollment
* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
* Participant has a significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
* Participant has a pre-existing hemi-diaphragmatic paralysis
* Participant has an acute illness, active systemic infection, or sepsis
* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
* Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \[\>=\] 60 milliliters \[mL\]/beat, regurgitant fraction \>= 50 percent \[%\], and/or effective regurgitant orifice area \>= 0.40 square centimeter \[cm\^2\])
* Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders \[ILR\])
* Participant has a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter)
* Participant is currently enrolled in an investigational study evaluating another device or drug
* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
* Participant has a life expectancy less than 365 days
DEVICE: VARIPULSE Catheter, DEVICE: FARAWAVE Catheter
Atrial Fibrillation
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07675135
Inclusion Criteria:
* Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
* Has EDS.
* If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
Exclusion Criteria:
* Has hypersomnia due to another medical disorder.
* Has a history of pitolisant use within 5 half-lives prior to Screening.
* Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
* Has any history of bipolar disorder or psychosis
* Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
* Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min.
* Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG). DRUG: HBS-301, OTHER: Placebo
EDS, Cataplexy, Fatigue, Narcolepsy
pitolisant, HBS-301, narcolepsy, EDS, cataplexy, fatigue
Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer (RAINFOL-03)
clinicaltrials@northshore.org
FEMALE
18 years and over
PHASE3
NCT07166094
Key Inclusion Criteria
* Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
* Participants must have received at least 1, but not more than 3, prior lines of therapy:
* Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
* If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.
* Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
* Prior induction plus maintenance is considered 1 line of therapy
* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
* Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
* Participants must have progressed radiographically on or after their most recent line of therapy
Key Exclusion Criteria
* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
* Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).
* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
DRUG: Rina-S, DRUG: IC
Endometrial Cancer, Recurrent or Progressive Endometrial Cancer
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
clinicaltrials@northshore.org
ALL
18 years to 100 years old
PHASE3
NCT07665437
Key
Inclusion Criteria:
* Signed informed consent must be obtained before any assessment is performed.
* Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
* Participant does not meet any treatment discontinuation criteria of the core study at Week 68.
Key Exclusion Criteria:
* Ongoing or planned use of prohibited HS or non-HS treatments.
* Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
* Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.
Other protocol-defined inclusion/exclusion criteria may apply. DRUG: Remibrutinib
Hidradenitis Suppurativa
BTK inhibitor, hidradenitis suppurativa, HiSCR, remibrutinib, Phase 3, extension study