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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

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Conditions: Shoulder Arthroplasty

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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

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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. 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. 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

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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

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Interventions: DEVICE: Cardiac Performance System (CPS)

Conditions: Cardiovascular Diseases

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

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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

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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

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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

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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

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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

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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

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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

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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

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A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD (PARAMOUNT)

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: NCT06713239

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Interventions: DEVICE: Cleerly Labs and Cleerly ISCHEMIA

Conditions: Coronary Artery Disease

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A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care (EDESIA)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 1 year and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06693531

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Interventions: DRUG: dupilumab

Conditions: Eosinophilic Esophagitis (EoE)

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Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

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: NCT06931405

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Interventions: DRUG: BLU-808, DRUG: Placebo

Conditions: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria

Keywords: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria, BLU-808, CIndU, CSU, Chronic Urticaria, CU, Cold Urticaria, ColdU, Symptomatic Dermographism, SD

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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

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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

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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

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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

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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.
• Cardiac amyloid infiltration demonstrated by: * Cardiac biopsy positive for TTR amyloid, OR * Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) scintigraphy with single-photon emission computed tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR * Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP scintigraphy with SPECT/CT combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE). Notes: * Non-invasive diagnostic pathway will be confirmed by a centralised expert review. * Bone tracer scintigraphy 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).
• Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm).
• Chronic HF (New York Heart Association \[NYHA\] Class I-IV) requiring ongoing treatment with a loop diuretic with: * At least 1 documented hospitalisation for HF, OR * 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). * 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. Note: Pre-existing echocardiogram up to 2 years old may be used. * 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 FISH or next generation sequencing (NGS) status * If IHC is 3+, pt IS ELIGIBLE regardless of FISH or NGS status * If IHC is 2+, FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE * If IHC is unknown and… * FISH is positive, independent of NGS results, the patient IS ELIGIBLE * 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 * Prior therapy with tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib is not allowed * 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

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis (TRuE-AD5)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 6 years to 17 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06832618

Show full eligibility criteria

Inclusion Criteria:

* Aged 6 to \< 18 years at the VC Day 1 visit. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria. * AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12 to \< 18 year olds (participant/parent/guardian may verbally report signs and symptoms of AD). * EASI score \> 7 at the screening and VC Day 1 visits. * IGA score of 3 at the screening and VC Day 1 visits. * Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits. * Itch NRS or WI NRS score ≥ 4 at the screening and VC Day 1 visits, defined as the average of the 7 days directly before the VC/Day 1 visit, with Itch NRS or WI NRS values available for at least 4 of the 7 days. * Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs as follows: * Inadequate response: * For TCSs: Inability of a given TCS to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment for 28 days or for the maximum duration recommended by the product prescribing information (eg, 14 days for superpotent TCSs), whichever is shorter and * For TCIs: Inability of a given TCI to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment according to the product prescribing information. Note: Documented (within 12 months before the screening visit) systemic treatment for AD (eg, oral corticosteroids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil) or phototherapy or photo(chemo)therapy can also be considered as a surrogate for inadequate response to TCSs and TCIs. • Intolerance: Clinically relevant side effects, safety risks, or skin tolerability issues that outweigh the potential treatment benefits and are the reason why a topical treatment could not be restarted or continued. Note: Documented history (more than 12 months prior to the screening visit) of clinically significant adverse reactions with use of TCSs and/or TCIs that in the opinion of the investigator outweigh the benefits of restarting treatment would also be considered as evidence of intolerance. • Contraindication: As defined in the product prescribing information. * Agreement by participants and guardians to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit, except as outlined in the protocol. * For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of prepubescent participants. Note: Female participants who have reached menarche must have a negative urine pregnancy test at the screening and baseline visits before the first application of study cream at baseline. They must also take appropriate precautions to avoid pregnancy from the screening visit through the safety follow-up visit. \- Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible. Note: A signed written ICF must be obtained for inclusion; see protocol.

Exclusion Criteria:

* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to the VC Day 1 visit. * Concurrent conditions and history of other diseases as follows: * Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the VC Day 1 visit. * Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before the VC Day 1 visit. * Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety. * Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds. * Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream. * Current or history of hepatitis B or C virus infection. * Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Any of the following clinical laboratory test results at screening: * Hemoglobin \< 10 g/dL. * Liver function tests: * Absolute neutrophil count \< 1000/μL. * Platelet count \< 100,000/μL. * AST or ALT ≥ 2 × ULN. * Alkaline phosphatase \> 1.5 × ULN. * Bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin isfractionated and direct bilirubin \< 35%) with the exception of Gilbert disease. * Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease equation). * Positive serology test results for HIV antibody. * Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant. * Use of any of the following treatments within the indicated washout period before the VC Day 1 visit: * 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor. * 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating (eg, mycophenolate or tacrolimus) agents. * 2 weeks or 5 half-lives, whichever is longer: strong systemic CYP3A4 inhibitors. * 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: COVID-19 vaccination is allowed. • 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno® creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study. * History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition. * Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study that is thought by the investigator to potentially impact the participant's AD. * Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug Protocol. * Pregnant or lactating participants or those considering pregnancy during the period of their study participation. * Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study. * Known allergy or reaction to any component of the study cream formulation. * In the opinion of the investigator, unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance). * Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities. * Employees of the sponsor, sponsor delegates (eg, contract research organizations), or investigators or are otherwise dependents of them. * The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code. * In the EU, participants considered incapacitated (according to CTR Article 31).

Interventions: DRUG: Ruxolitinib, DRUG: Vehicle Cream

Conditions: Atopic Dermatitis

Keywords: Atopic Dermatitis, Ruxolitinib

I'm interested

TECTONIC CAD IVL IDE Study (TECTONIC)

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: NCT06885177

Show full eligibility criteria

Inclusion Criteria:

• Subject must be at least 18 years of age.
• Subject must sign and date a written informed consent form before any study-specific tests or procedures are performed.
• Subject is able and willing to comply with all protocol requirements.
• Subject has native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI.
• For subject with unstable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to the upper reference limit (URL) within 12 hours prior to the procedure.
• For subject with stable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to 1.5 times the URL. Blood for cardiac biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath. 6a. If drawn prior to the procedure, cardiac biomarker (troponin) must be less than or equal to 1.5x the URL within 12 hours prior to the index procedure. 6b. If drawn at the time of the procedure from the side port of the sheath prior to any intervention, cardiac biomarker results need to be analyzed and resulted prior to registering the subject into the study. 7\) Left ventricular ejection fraction (LVEF) ≥ 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for these criteria; may be assessed at time of index procedure). 8\) Lesions in non-target vessels requiring PCI may be treated either: a. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or b. \>24 hours prior to the study procedure if the procedure was successful and uncomplicated; or c. \>30 days after the study procedure (in 1 or 2 non-target vessels). Anatomic Inclusion Criteria Anatomic inclusion criteria are applied at the time of cardiac catheterization for PCI by the investigator and are visually assessed by angiography. The anatomic inclusion criteria include the following:
• The target lesion must be a single de novo coronary lesion that has not been previously treated with ANY interventional procedure.
• Single de novo target lesion stenosis of protected left main coronary artery (LMCA), or left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with: a. Stenosis of ≥70% and \<100% or b. Stenosis ≥50% and \<70% with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or RFR/iFR \<0.89 (or any other non-hyperemic pressure index), or IVUS or OCT minimum lumen area ≤4.0 mm\^2
• The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm.
• The lesion length must not exceed 36 mm. 4a) Tandem lesions are allowed and considered one lesion if they are \<5 mm apart and as long as the total lesion length does not exceed 36 mm, except for distal lesions without planned treatment and that are in vessels ≤2.0 mm in diameter.
• The target vessel must have TIMI grade 3 flow at baseline; may be assessed after pre-dilatation.
• Evidence of calcification at the lesion site by, a. Angiography, with fluoroscopic radiopacities noted as severe (radiopacities noted without cardiac motion before contrast injection compromising both sides of the arterial lumen) OR b. IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section.
• Ability to pass a 0.014" guide wire across the lesion.

Exclusion Criteria:

• Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
• Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the Primary endpoint. For the purposes of this criterion, "participation" is defined as being registered in another trial.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. For subjects with childbearing potential, a urine or blood pregnancy test is required within 7 days prior to index procedure to verify that subject is not pregnant. Note: Investigators should instruct female patients of childbearing potential to use safe contraception for 12 months after the procedure (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release). It is acceptable to include subjects having a sterilized regular partner.
• Subject unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months.
• Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.
• Subject experienced an acute MI (either ST-segment elevation myocardial infarction, STEMI or non-ST-segment elevation myocardial infarction, NSTEMI) within 7 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's ULN.
• Subject has New York Heart Association (NYHA) class III or IV heart failure.
• Subject has renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis.
• Subject has a history of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit.
• Subject has an active peptic ulcer or upper gastrointestinal bleeding within 6 months.
• Subject has an untreated pre-procedural hemoglobin \<8 g/dL or intention to refuse blood transfusions if one should become necessary.
• Subject has a coagulopathy, including but not limited to platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment).
• Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders.
• Subject has uncontrolled diabetes defined as a HbA1c ≥10%.
• Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics.
• Subject in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia).
• Subject has uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg).
• Subject with a life expectancy of less than 1 year.
• Subject has had interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure.
• Subject has planned interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure.
• Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery.
• Subject has a previous stent in the target vessel implanted within the last year.
• Planned use of atherectomy, scoring or cutting balloon, ultra-high pressure non-compliant balloon, excimer laser coronary atherectomy (ELCA), drug-coated balloon (DCB) or any investigational device other than the current study device Anatomic Exclusion Criteria Anatomic exclusion criteria are applied at the time of cardiac catheterization for PCI by the investigator and are visually assessed by angiography. The anatomic exclusion criteria include the following:
• Unprotected LMCA diameter stenosis \>30%.
• Target lesion has a myocardial bridge.
• Target vessel is excessively tortuous, defined as the presence of 2 or more bends \>90 degrees or 3 or more bends \>75 degrees.
• Definite or possible thrombus in the target vessel.
• Evidence of aneurysm in target vessel within 10 mm of the target lesion.
• Target lesion in ostial location (within 5 mm of the vessel origin) of the LAD, LCX, or RI and per the physician's discretion would require stenting into the LMCA.
• Target lesion is a bifurcation with the side branch having ostial diameter stenosis ≥50% and is an intervenable target (e.g. ≥2.0mm in diameter).
• Second lesion with \>50% stenosis in the same target vessel as the target lesion, including planned treatment of side branches and distal lesions that are ≥2.0 mm in diameter.
• Target lesion is located in a native vessel that can only be reached by going through an existing coronary artery bypass graft.
• Any previous stent within 10 mm of the target lesion.
• Imaging evidence of a dissection (NHLBI dissection grades D-F) in the target vessel after guide wire passage and/or prior to start of IVL treatment

Interventions: DEVICE: Experimental

Conditions: Coronary Artery Calcification, Coronary Artery Disease, Stenotic Coronary Lesion

Keywords: Lithotripsy, Coronary Artery Calcification, PCI (Percutaneous Coronary Intervention), De Novo Coronary Arteries

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)/ Peripherial 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 (including motor-predominant 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. Response must be an objective clinically meaningful improvement defined by at least one of the following: ≥1 point decrease in adjusted INCAT score, ≥4 points increase in I-RODS centile score, ≥3 points increase in the MRC-SS, ≥8 kilopascal improvement in mean grip strength (1 hand), or an equivalent improvement based on information documented in medical records as per the Investigator's judgment.
• Participant must be on a stable maintenance dosage of IVIg, defined as no change greater than 10% in frequency or dose of IVIg within 8 weeks prior to Screening, and remaining stable until baseline.
• 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: 0.4 to 1 g/kg every 2 to 6 weeks. The IVIg maintenance dosing regimen should be equivalent or higher than a weekly dose of 0.1 g/kg body weight (for example, 0.3 g/kg every 3 weeks).
• 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.
• All participants must agree to use contraception methods during and after the study as required.
• Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A male participant is eligible to participate if they agree to the following during the study intervention period and for at least 55 weeks after the last dose of study medication. --Refrain from donating or cryopreserving sperm. PLUS, either: --Be abstinent from heterosexual intercourse (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR --Must agree to use contraception/barrier as detailed below:
• A male condom and an additional highly effective contraceptive method (Contraceptive and barrier guidance per protocol) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: * Is a woman of nonchildbearing potential (WONCBP) as defined by the protocol. OR * Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of \<1% per year), as described in the protocol during the study intervention period (to be effective before starting the intervention) and for at least 55 weeks after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
• 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 (HbA1c glycated hemoglobin \>7% at the Screening visit).
• Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring 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.
• Treatment with plasma exchange within 8 weeks prior to Screening.
• Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (except ≤20 mg/day of prednisone or equivalent 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.
• Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening.
• 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 prior to riliprubart dosing, or until return of B-cell counts to normal levels, whichever is longer.
• 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: * HBsAg * Anti-HBc; unless anti-HBs Ab X are also positive, indicating natural immunity. * Anti-HCV antibodies. * 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.
• Treatment with efgartigimod within 8 weeks prior to screening. 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

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 45 years old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06316297

Show full eligibility criteria

Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator * Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol \[PEG\], polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine * Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica) * Use of any acne-affecting treatment without an appropriate washout period * Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration * Previous vaccination against C. acnes with an investigational vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Interventions: BIOLOGICAL: Acne mRNA vaccine, OTHER: Placebo

Conditions: Acne

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Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast 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: NCT05929768

Show full eligibility criteria

Inclusion Criteria:

* Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER \< 5%, PR \< 5%, and HER2 negative (per 2020 American Society of Clinical Oncology \[ASCO\] College of American Pathologists \[CAP\] guidelines) * NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician * Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either * T2-T4, N0, M0 or * T1-T3, N1-2, M0 * Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status * Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization * Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria * Participants must not have T4/N+, any N3, or inflammatory breast cancer * Participants must not have metastatic disease (M1) * Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer * Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer * Participants must not have current or anticipated use of other investigational agents while participating in this study * Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents * Participants must not have severe hypersensitivity (\>= grade 3) to pembrolizumab or any of its excipients * Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) * Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization * Participants must be \>= 18 years old * Participants must have Zubrod performance status of 0-2 * Participants with evidence of peripheral neuropathy must have it at =\< grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization * Participants must have a complete medical history and physical exam within 28 days prior to randomization * Hemoglobin \>= 9.0 g/dL or \>= 5.6 mol/L (within 28 days prior to randomization) * (Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks) * Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to randomization) * Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to randomization) * Platelets \>= 100 x 10\^3/uL (within 28 days prior to randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN), OR direct bilirubin =\< IULN for participants with total bilirubin \> 1.5 x IULN (unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional IULN) (within 28 days prior to randomization) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) * Participants must have a serum creatinine =\< the IULN OR calculated creatinine clearance \>= 50 mL/min/1.73m\^2 using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration * Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction \>= 50% as assessed by either echocardiography (ECHO) or multigated acquisition scan (MUGA) assessed within 28 days prior to registration. 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 and must be class 2B or better * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization * 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 randomization, if indicated * Note: No testing for Hepatitis B is required unless mandated by local health authority * 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 randomization, if indicated * Note: No testing for hepatitis C is required unless mandated by local health authority * Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator * Participants must not have uncontrolled hypertension in the opinion of the treating investigator * Participants must not have had a major surgery within 14 days prior to randomization. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator * Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia * Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization * Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment * Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis * Participants must not have received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed * 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 treatment regimen * Participants must not be pregnant or nursing. 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 have one (1) physical 4-5-micron single hematoxylin and eosin (H\&E) slide from the archival pretreatment diagnostic biopsy available for submission * 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 questionnaires in English, Spanish, or French must be offered the opportunity to participate in the Patient-Reported Outcome study * 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 * As part of the 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

Interventions: PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Cyclophosphamide, DRUG: Docetaxel, DRUG: Doxorubicin, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, PROCEDURE: Surgical Procedure

Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma

I'm interested

Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases, PREEMPT Trial

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: NCT06745024

Show full eligibility criteria

Interventions: OTHER: Best Practice, PROCEDURE: Biospecimen Collection, OTHER: Bone Metastases Treatment, PROCEDURE: Computed Tomography, PROCEDURE: Conventional Radiotherapy, PROCEDURE: Magnetic Resonance Imaging, OTHER: Patient Observation, OTHER: Questionnaire Administration, RADIATION: Stereotactic Body Radiation Therapy

Conditions: Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm

I'm interested

Rapid Evacuation and Access of Cerebral Hemorrhage Trial (REACH)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 70 years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06870812

Show full eligibility criteria

Inclusion Criteria:

* Age 18-70 years * Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia include the caudate, putamen, and pallidum to the capsula externa and excludes the thalamus) * ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement * Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the onset is unclear, then the onset will be considered the time that the subject was last known to be well. * Glasgow Coma Score (GCS) 5 - 14 * Historical Modified Rankin Score 0 or 1

Exclusion Criteria:

* Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (less than 1 year) ICH, as diagnosed with radiographic imaging * NIH Stroke Scale (NIHSS) less than or equal to 5 * Bilateral fixed dilated pupils * Extensor motor posturing * Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles * Primary thalamic ICH or basal ganglia hemorrhage with involvement \> 25% of thalamus * Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar * Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that clinically significant coagulopathy is not present after targeted correction) * Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site * Uncorrected coagulopathy or known clotting disorder * Known platelet count less than 75,000 or known international normalized ratio (INR) greater than 1.4 after correction * Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH * End-stage renal disease * Patients with a mechanical heart valve * End-stage liver disease * History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal * Known life expectancy of less than 6 months before ICH * No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization * Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional/observational studies are eligible * Inability or unwillingness of the subject or legal guardian/representative to give written informed consent * Homelessness or inability to meet follow-up requirements

Interventions: PROCEDURE: Surgical management, OTHER: Medical Management

Conditions: Stroke Hemorrhagic

Keywords: Intracerebral hemorrhage, minimally invasive surgery, Blood clot

I'm interested

A Registry for People With Lung Cancer

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06424327

Show full eligibility criteria

Interventions: OTHER: Patient-Reported Outcomes Measurement Information System

Conditions: Lung Cancer, Lung Cancer Stage I

Keywords: lung cancer, lung cancer stage 1, segmentectomy, Memorial Sloan Kettering Cancer Center, 24-127

I'm interested

Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) (NAVIGATE)

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: NCT06464926

Show full eligibility criteria

Inclusion Criteria:

* Willing and able to complete the informed consent process * Stated willingness to comply with all study procedures and availability for the duration of the study * Aged ≥18 years at time of informed consent * Chronic, drug-refractory nausea that: a) has been present for more than 6 months, and b) has been active within the last 3 months prior to consent * Patient is able to complete ANMS GCSI-DD surveys on a compatible smart device with: a) a minimum of four (4) ANMS GCSI-DD entries per week for two consecutive weeks, and b) an average ANMS GCSI-DD score for nausea severity of ≥2.5 during the same two-week period * Refractory or intolerant to two or more of the following antiemetic drug classes: antihistamines, phenothiazines, serotonin type 3 receptor antagonists, dopamine type 2 receptor antagonists, anticholinergics, neurokinin receptor antagonists * Medically stable, in the opinion of the investigator, during the month prior to consent, with no planned modifications to medical therapy during the course of the study * Normal gastric emptying as assessed by a qualifying gastric emptying test performed within 2 years of consent if no prior pyloric transection therapy, or within 2 years of consent and after the most recent pyloric transection therapy * Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum) performed within 1 year of consent if no prior pyloric transection therapy, or within 1 year of consent and after the most recent pyloric transection therapy

Exclusion Criteria:

* Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements * Pyloric transection therapy completed within 1 year of consent * Documented gastrointestinal (GI) obstruction or pseudo-obstruction * History of primary swallowing disorders * History of primary psychogenic vomiting * History of primary eating disorder * History of cyclic vomiting syndrome * History of rumination syndrome * History of scleroderma * History of amyloidosis * History of cannabis hyperemesis syndrome * Active H. pylori infection * Evidence of bezoar during most recent endoscopy * Previous gastric surgery of any type other than a pyloric transection therapy (i.e., pyloroplasty, pyloromyotomy, POP, or G-POEM) * Uncontrolled thyroid disorder, in the opinion of the investigator * History of seizures disorders * Hemoglobin A1c \>8.0% * Peritoneal dialysis or unstable hemodialysis * Parenteral or enteral nutritional support * Active pancreatitis * History of organ transplant, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease * Other GI tract diseases and disorders that the investigator believes may have caused the patient's drug-refractory nausea and/or vomiting * Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of consent * Opioid use * Current cannabis/cannabinoid use that exceeds: 3 days of usage per week, or 2 occurrences during each day of use, or 3 grams of total usage per week * Heavy alcohol use, defined as: for men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more drinks on any day or 8 or more per week * Injection of Botox into the pyloric sphincter within 6 months of consent * Active major levels of anxiety/depression, as determined by the investigator * History of other clinically significant disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact the validity of the study results * Life expectancy \<1 year * Pregnant or breastfeeding at the time of consent or intend to become pregnant during the study * Any underlying disease leading to follow-up by MRI outside of current MR conditional indications * Glucagon-like peptide 1 (GLP-1) agonist drug use within 6 months of consent * Participation in other investigational clinical studies * Existing or prior gastric electrical stimulator implantation

Interventions: DEVICE: Enterra Therapy System

Conditions: Nausea, Vomiting

Keywords: Chronic, Nausea, Vomiting, Gastric Electrical Stimulation

I'm interested

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years to 17 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07213973

Show full eligibility criteria

Interventions: DRUG: Povorcitinib

Conditions: Hidradenitis Suppurativa (HS)

Keywords: Hidradenitis Suppurativa, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis

I'm interested

Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer (STRIKE)

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: NCT06661720

Show full eligibility criteria

Inclusion Criteria:

* • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy) * Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted * Intermediate-high risk RCC: * pT2 grade 4 or sarcomatoid features, N0M0 * pT3 any grade N0, M0 * High-risk RCC * pT4, any grade, N0, M0 * pT, any stage., any grade, N+, M0 * cM1 no evidence of disease (NED) RCC * Participants who have had resection of primary tumor (radical or partical nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous) * Surgery (radical or partial nephrectomy or metastasectomy or ablation) \> 4 weeks but =\< 16 weeks prior to study registration with no ongoing complications from surgery * No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis * No prior systemic treatment for RCC * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%) * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 8 g/dL * Total bilirubin =\< 3 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x upper limit of normal (ULN) * Calculated (calc.) creatinine clearance \>= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial) * Urine protein =\< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \< 2mg/mg * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =\< 14 days prior to registration * HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Hepatitis * Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible * Hepatitis C: 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 * Cardiac Disease: 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 IIB or better * No history of myocarditis * No history of clinically significant pneumonitis * No uncontrolled hypertension (systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart * No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration * No serious/active infection requiring parenteral antibiotics * No moderate or severe hepatic impairment (child-Pugh B or C) * No significant bleeding disorders within 1 month prior to registration, for example: * Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher * Hemoptysis of pulmonary bleeding grade 3 or higher * Hematuria or other genitourinary bleeding grade 3 or higher * No history of allogeneic organ transplantation * No history of allergy of hypersensitivity to study drugs or components * No condition requiring systemic treatment with either corticosteroid (\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease * No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration * 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 * No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \> 10 mg/day, or immunosuppressive drugs) with the following exceptions: * Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * Brief (\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care * Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded * Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded * Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Interventions: BIOLOGICAL: Pembrolizumab, DRUG: Tivozanib, PROCEDURE: Biospecimen Collection, PROCEDURE: MRI, PROCEDURE: Computed Tomography, PROCEDURE: Biopsy, OTHER: Questionnaire Administration

Conditions: Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8

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Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure (SYNCHRONICITY)

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: NCT07069738

Show full eligibility criteria

Inclusion Criteria:

• Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law
• Patient meets a guideline-based indication for a de novo CRT-D device
• Primary prevention indication for ICD therapy
• Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months) using an appropriate method of assessment (i.e. Echo, MRI, etc)
• NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)\* for at least 3 months \*GDMT is defined as all four drug classes listed below for at least 3 months prior to enrollment unless the investigator provides justification (e.g., contraindicated, not tolerated or cost): Renin Angiotensin System Inhibitors (ACE, ARB, or ARNI) Evidence based betablockers (metoprolol succinate, carvedilol, bisoprolol) Mineralocorticoid antagonists SGLT2 Inhibitor medications
• Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1, V2, V5, V6) within 3 months of enrollment
• Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
• Patient is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally authorized representative (LAR) is not allowed)
• Patient plans to remain geographically stable (not permanently moving to another location) and can commit to all study participation requirements (procedure, follow-up visits and testing requirements)

Exclusion Criteria:

• Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
• Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes of expected percentage of cardiac physiologic pacing (CPP) delivery below 95% at the time of enrollment
• Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
• Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
• Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
• Prior or planned mechanical or bioprosthetic tricuspid valve replacement
• Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment
• Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment
• History of heart transplantation or left ventricular assist device (LVAD) implantation
• Less than 1 year of life expectancy at the time of enrollment
• Anticipated heart transplantation or LVAD implantation within 1 year of enrollment
• History of ventricular septal defect (VSD)
• Complex congenital heart disease
• Documented diagnosis of cardiac amyloidosis
• Known occlusion or other reason limiting central venous access for transvenous leads
• Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion)
• Patient currently requiring dialysis
• Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
• Patient with contrast dye allergy or unwilling/able to undergo pre-treatment with steroids and/or diphenhydramine
• Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome
• Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.

Interventions: DEVICE: CRT-D with a Quadripolar LV lead, DEVICE: CRT-D with INGEVITY+ pace/sense lead

Conditions: Heart Failure - NYHA II - IV

Keywords: Heart Failure, Conduction System Pacing, Primary Prevention, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing

I'm interested

Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH 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: NCT06577441

Show full eligibility criteria

Inclusion Criteria:

* GENERAL MYLEOMATCH REGISTRATION CRITERIA: * Patients must be registered to the Master Screening and Reassessment Protocol (MSRP) and assigned to this protocol by the MATCHBox Treatment Verification Team. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. * Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor \[g-CSF\], thrombopoietin \[TPO\] agonist), lenalidomide or luspatercept is allowed with a maximum limit of 1 month of exposure. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects. * Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required. * REGISTRATION ELIGIBILITY CRITERIA (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. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. * REGISTRATION ELIGIBILITY CRITERIA (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. * REGISTRATION ELIGIBILITY CRITERIA (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. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN). * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)/ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN) * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Enasidenib

Conditions: Myelodysplastic Syndrome

I'm interested

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Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure (SYNCHRONICITY)

Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

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