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Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 59 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05554393

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Inclusion Criteria:

* Participants must have been registered to master screening and re-assessment protocol (MYELOMATCH) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH * Previously untreated, de novo acute myeloid leukemia (AML) defined by \>= 20% myeloblasts in the peripheral blood or bone marrow (as defined by the current World Health Organization \[WHO\] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML: * Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11 * CEBPA biallelic mutations * NPM1 mutation * AML with PML-RARalpha * AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23/KMT2 rearrangements * AML with FLT3-ITD mutation * Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease * Age 18-59 years at time of induction therapy * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 * Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment) * Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase \[SGPT\]) and/or alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase \[SGOT\]) =\< 3 × institutional ULN (must be done within 10 days of enrollment) * Cardiac ejection fraction \>= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment) * Calculated creatinine clearance \>= 30 mL/min; Clearance to be calculated using Cockcroft formula (must be done within 10 days of enrollment) * White blood cells (WBC) must be =\< 25 x 10\^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +/- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted * 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 * 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 * Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Women of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate * Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial * In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment * Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible

Exclusion Criteria:

* Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out * Patients who are receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax * Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study * Patients with isolated myeloid sarcoma are not eligible * Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example): * Active, uncontrolled bacterial, fungal, or viral infection

Interventions: DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, PROCEDURE: Echocardiography Test, PROCEDURE: Multigated Acquisition Scan, DRUG: Venetoclax

Conditions: Acute Myeloid Leukemia

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Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age:

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05564377

Show full eligibility criteria

Inclusion Criteria:

* Patient must have measurable disease * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50% * Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider * All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL) * Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria: * Patients must have progressed on at least one line of standard systemic therapy OR * Patients whose disease has no standard treatment that has been shown to prolong overall survival * Patient must meet one of the following requirements: * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \[CR\] or partial response \[PR\]) to any intervening therapy after collection of the tissue * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only * NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial

Interventions: DRUG: Alpelisib, DRUG: Binimetinib, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, DRUG: Fluorouracil, DRUG: Fulvestrant, DRUG: Ipatasertib, DRUG: Leucovorin, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Neratinib Maleate, DRUG: Nilotinib Hydrochloride Monohydrate, DRUG: Olaparib, DRUG: Oxaliplatin, DRUG: Paclitaxel, DRUG: Palbociclib, BIOLOGICAL: Panitumumab, PROCEDURE: Positron Emission Tomography, DRUG: Selumetinib Sulfate, DRUG: Sotorasib

Conditions: Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm

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Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual) (PAUSEVirtual)

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: NCT06844227

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Conditions: Atrial Fibrillation (AF)

Keywords: anticoagulation, Atrial Fibrillation, Surgery, Oral Anticoagulant, Blood Thinner, DOAC, Interruption, Perioperative, Virtual, PAUSE

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A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE4

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06042920

Show full eligibility criteria

Key

Inclusion Criteria:

Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis * Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator. * Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1. * Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1. * A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed. * Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1. * Deemed by the investigator to be a candidate for phototherapy or systemic therapy. * Failed to respond to, or intolerant of ≥ 1 topical therapy. Inclusion Criteria for Genital Psoriasis * Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator. * Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1. * Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1. * Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1. * Deemed by the investigator to be a candidate for phototherapy or systemic therapy. * Failed to respond to, or intolerant of ≥ 1 topical therapy. Key

Exclusion Criteria:

Target Disease Exceptions * Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1. Other protocol-defined inclusion/exclusion criteria apply.

Interventions: DRUG: Deucravacitinib, DRUG: Placebo

Conditions: Palmoplantar Psoriasis, Genital Psoriasis

Keywords: Deucravacitinib, BMS-986165, SOTYKTU, Plaque psoriasis

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NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL) (NSAIDHEAL)

Contact(s):

Kevin Hellman, PHD - khellman@northshore.org

Sex: FEMALE

Age: 18 years to 35 years old

Phase: PHASE4

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06861920

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Inclusion Criteria:

* aged 18-35 * individuals who menstruate, with painful periods * regular menstrual cycles (every 22-35 days)

Exclusion Criteria:

* presence of active pelvic or abdominal malignancies (primary or metastatic) * conditions associated with the absence of regular menses such as polycystic ovarian syndrome, pregnancy, or any current use of continuous hormonal medication or contraceptive * unable to read or comprehend the informed consent in English * presence of other diagnosed chronic back or pelvic pain conditions (including chronic back pain, fibromyalgia, bladder pain syndrome, irritable bowel syndrome, vulvar pain syndrome, and endometriosis-associated pelvic pain) * having another diagnosed/symptomatic chronic pain condition besides migraines with an average pain score \>3/10 in the last month when not consuming pain relievers, or that requires daily treatment with opioids (ex. hydrocodone, oxycodone, codeine, morphine, hydromorphone, tapentadol, tramadol) or neuromodulators (also known sometimes as antidepressants \[ex. amitriptyline, nortriptyline, imipramine, duloxetine, milnacipran, venlafaxine\] or antiseizure medications \[ex. topiramate, gabapentin, pregabalin, carbamazepine, lamotrigine\]) * current or past history of stomach ulcers * current or past history of gastrointestinal (GI) bleeding * diagnosis of peptic ulcer disease * current or past history of renal disorders * current or past history of adrenal dysfunction * diagnosis of liver disorders * diagnosis of chronic acid reflex (i.e. GERD) * Diagnosis of Crohn's disease or ulcerative colitis * Coagulopathy * Prolactinoma * Von Willebrand disease * Platelet disorders * High blood pressure that is difficult to manage * gastrointestinal conditions or surgeries that affect naproxen absorption * bleeding disorders * heart failure * a history of stroke * a history of heart attack * active genitourinary or sexually transmitted infection * allergy to non-steroidal anti-inflammatory drugs (NSAIDs) or their ingredients * individuals who take the following medications: anticoagulants (i.e. warfarin), lithium, diuretics, antacids, angiotensin-converting enzyme (ACE) inhibitors, methotrexate, cholestyramine, or probenecids. * Unmanaged diabetes (i.e. Fasting Blood Glucose: ≥ 126 mg/dL (≥ 7.0 mmol/L), Non-Fasting/Random Blood Glucose: ≥ 200 mg/dL (≥ 11.1 mmol/L), Hemoglobin A1c (HbA1c): ≥ 6.5%) * Uncontrolled thyroid function (i.e. Hypothyroidism (Underactive Thyroid): Thyroid-Stimulating Hormone (TSH): \> 4.5 mIU/L (mild) or \> 10 mIU/L (severe) Free T4: Below the lower end of the reference range (usually \< 0.9 ng/dL) * Hyperthyroidism (overactive thyroid) (i.e. TSH: \< 0.4 mIU/L (Suppressed or undetectable), Free T4: Above the upper end of the reference range (usually \> 2.0 ng/dL) * Liver dysfunction (i.e. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or bilirubin (unless known diagnosis of Gilbert's syndrome) ≥ 1.5 times the upper limit of the reference range) * Kidney dysfunction (i.e. Serum creatinine \> 1.1 mg/dL.)

Interventions: DRUG: Naproxen Sodium 550mg, DRUG: Placebo, DRUG: Extended Release Acetaminophen (650 mg)

Conditions: Dysmenorrhea, Chronic Pelvic Pain, Pelvic Pain

Keywords: Painful Periods, NSAIDs, Chronic Pelvic Pain, Pelvic Pain, Periods

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Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (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: NCT06317649

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Inclusion Criteria:

* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status), organ dysfunction, or disease biology * Patient must have a morphologically confirmed diagnosis of AML as determined by the site and confirmed by the treatment verification team, excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11 * Patient must have no prior therapy for AML with the exception of hydroxyurea, all-trans retinoic acid (ATRA), cytarabine-based emergency therapy or leukapheresis to ensure white blood cells (WBC) \< 25,000/mm\^3 prior to starting venetoclax treatment * Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors * Patient must have the FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol * Patient must be assigned to this protocol by the MYELOMATCH Protocol * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients who are able to conceive or father children and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Total bilirubin ≤ 2 X institutional upper limit of normal (ULN), unless thought to be elevated due to disease involvement or Gilbert's syndrome, in which case bilirubin ≤ 3 x ULN is allowed (must be obtained ≤ 14 days prior to randomization) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN (must be obtained ≤ 14 days prior to randomization) * Creatinine clearance ≥ 30 mL/min (must be obtained ≤ 14 days prior to randomization) * Either measured or estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * Patients who meet the criteria below must have had an electrocardiogram (ECG) performed with a corrected QT interval using Fridericia's correction (QTcF) interval within normal limits: * Patient \< 75 years old with a history of cardiac arrythmia, atrial fibrillation, or irregular QTcF interval OR * Patient \< 75 years old with known genetic predisposition to long QT syndrome OR * Any patient ≥ 75 years old OR * Any patient at risk for electrolyte abnormalities, including tumor lysis syndrome * Normal limits are QTcF ≤ 450 ms for males and QTcF ≤ 460 ms for females. Corrected QT interval method (QTcF) may follow institutional standards * NOTE: Since older patients and patients with cardiac disease are at risk for prolonged QTcF and many will require supportive care with agents that affect the QTcF, an ECG is recommended if clinically indicated as noted above. If the QTcF is prolonged (\> 450 ms for males and \> 460 ms for females), they should be treated on the Tier Advancement Pathway (TAP) instead of MM1OA-EA02. In patients where ECG is not clinically indicated, QTcF does not need to be documented * 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 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 * Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug * 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 * 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 2 or better * Patient must not have an uncontrolled infection

Interventions: DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Gilteritinib, DRUG: Venetoclax

Conditions: Acute Myeloid Leukemia

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Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis (ONWARD3)

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: NCT06846541

Show full eligibility criteria

Interventions: DRUG: Open-Label ESK-001, DRUG: Blinded ESK-001, DRUG: Placebo

Conditions: Plaque Psoriasis, Psoriasis (PsO), Psoriasis, Moderate Psoriasis, Severe Psoriasis

Keywords: Psoriasis, PASI, Safety, ESK-001

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Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

Contact(s):

Kate Honeyfield - KHoneyfield@northshore.org

Sex: FEMALE

Age: 17 years and over

Phase:

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06898034

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Interventions: OTHER: Ultrasound

Conditions: Pregnancy Related, Post Partum Hemorrhage

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A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05902988

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Interventions: DRUG: VLS-1488

Conditions: Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary, Squamous Non-small-cell Lung Cancer, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Ovarian Carcinosarcoma, Uterine Carcinosarcoma, Uterine Serous Carcinoma, Endometrium Cancer, Chromosomal Instability

Keywords: KIF18A Inhibitor, HGSOC, TNBC, HNSCC, sqNSCLC

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A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 16 years to 80 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06430801

Show full eligibility criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study. * Has moderately to severely active CD. * Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies. * Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion Criteria:

* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis. * Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement. * Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study. * Has current stoma or need for colostomy or ileostomy. * Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. * Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD. * Has surgical bowel resection within 3 months of study. * Has prior or current gastrointestinal dysplasia. * Has chronic infection requiring ongoing antimicrobial treatment. * Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years. * Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * Has active tuberculosis. * Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection. * Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

Interventions: DRUG: IV Tulisokibart, DRUG: SC Tulisokibart, OTHER: IV Placebo, OTHER: SC Placebo

Conditions: Crohn's Disease

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RECOVER-SLEEP: Platform Protocol

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06404086

Show full eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

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

Keywords: PASC

I'm interested

The CONFORM Pivotal Trial

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: NCT05147792

Show full eligibility criteria

Inclusion Criteria:

• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, or permanent)
• High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
• Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
• Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
• Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care
• Able to comply with the protocol-specified medication regimen and follow-up evaluations
• The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).

Exclusion Criteria:

• Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure)
• Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)
• History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
• Documented active systemic infection
• Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment
• Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
• Recent (within 30 days of index procedure) stroke or transient ischemic attack
• Recent (within 30 days of index procedure) myocardial infarction
• Vascular access precluding delivery of implant with catheter-based system
• Severe heart failure (New York Heart Association Class IV)
• Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
• Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3
• Known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or to device materials (e.g., nickel, titanium), or the subject has contrast sensitivity that cannot be adequately pre-medicated
• Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
• Unable to undergo general anesthesia
• Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years
• A condition which precludes adequate transesophageal echocardiographic assessment Echo exclusion criteria:
• Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial)
• Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE
• Left ventricular ejection fraction (LVEF) \<30%
• Moderate or large pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
• Atrial septal defect that warrants closure
• High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \> 15 mm) or large shunt (early \[within 3 beats\] and/or substantial passage of bubbles, e.g., \>20)
• Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
• Evidence of cardiac tumor

Interventions: DEVICE: CLAAS, DEVICE: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

Conditions: Atrial Fibrillation, Stroke

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 65 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06976606

Show full eligibility criteria

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

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

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06580314

Show full eligibility criteria

Inclusion Criteria:

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

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

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

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 2 weeks to 8 weeks old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06315738

Show full eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Interventions: BIOLOGICAL: ST266

Conditions: Necrotizing Enterocolitis

Keywords: Necrotizing Enterocolitis, NEC

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 100 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06865651

Show full eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Interventions: DRUG: Remibrutinib, DRUG: Placebo

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

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

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 85 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06736574

Show full eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction

Keywords: CK-1827452, omecamtiv mecarbil

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06203600

Show full eligibility criteria

Inclusion Criteria:

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

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

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

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06934226

Show full eligibility criteria

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

Conditions: Plaque Psoriasis

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 50 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07001800

Show full eligibility criteria

Interventions: DRUG: Ataciguat, DRUG: Placebo

Conditions: Moderate Aortic Valve Stenosis

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

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 21 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06056271

Show full eligibility criteria

Interventions: DEVICE: AF Ablation

Conditions: Atrial Fibrillation

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years to 80 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05183646

Show full eligibility criteria

DOUBLE BLIND PERIOD

Inclusion Criteria:

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

Exclusion Criteria:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Interventions: DRUG: DMX-200, DRUG: Placebo

Conditions: FSGS

Keywords: fsgs, focal segmental glomerulosclerosis, kidney disease

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 45 years and over

Phase: PHASE3

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06254469

Show full eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Interventions: DRUG: [F-18]Flornaptitril

Conditions: Alzheimer Disease, Chronic Traumatic Encephalopathy

I'm interested

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes (ONWARDS 11)

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: NCT07076199

Show full eligibility criteria

Interventions: DRUG: Insulin icodec, DRUG: Insulin glargine, DRUG: Insulin aspart

Conditions: Diabetes Mellitus, Type 1

I'm interested

Autonomic Neural Blockade in Bariatric Surgery

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 90 years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07104825

Show full eligibility criteria

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

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

Keywords: Autonomic, blockade, bariatric surgery

I'm interested

Total Shoulder Arthroplasty Multi-Center Registry

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 100 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03511586

Show full eligibility criteria

Conditions: Shoulder Arthroplasty

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06873945

Show full eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Exclusion Criteria:

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

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

Conditions: Alopecia Areata

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

I'm interested

Alleviant ALLAY-HFrEF Study

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06812533

Show full eligibility criteria

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

Conditions: Heart Failure

I'm interested

Pivotal Study for the Cardiac Performance System (CPS)

Contact(s):

Principal Investigator - clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase:

Healthy Volunteers:

System ID: NCT06870591

Show full eligibility criteria

Interventions: DEVICE: Cardiac Performance System (CPS)

Conditions: Cardiovascular Diseases

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

I'm interested

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

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06337318

Show full eligibility criteria

Inclusion Criteria:

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

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

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

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