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Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia (RECOVER)

clinicaltrials@northshore.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT06449378
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Inclusion Criteria:

• Subject has provided informed consent
• Subject is 18 years of age or older at the time of consent
• Subject is undergoing a planned, elective, open, single-staged repair of a midline primary or incisional ventral hernia using retrorectus/retromuscular mesh placement with or without Transversus Abdominis Release (TAR)
• Subject is expected to meet the criteria for:
• In the US: a class I / clean wound as defined by the CDC (Centers for Disease Control and Prevention) wound classification
• In Europe: a class I / clean wound or a class II / clean-contaminated wound as defined by the CDC wound classification in compliance with these conditions: * No break in the sterile technique, and * Entry into gastrointestinal tract with no or minimal spillage
• Subject has at least one of the following comorbid factors impairing wound healing:
• Current smokers (subject who has smoked 100 cigarettes in his or her lifetime and who currently smokes) Note: Use smoking status prior to preoperative optimization for inclusion assessment.
• Smokers with a minimum 20 pack year history (including former smokers)
• Obesity, defined as body Mass Index (BMI) between 30kg/m2 and 39.9kg/m2
• Chronic Obstructive Pulmonary Disease (COPD)
• Diabetes mellitus
• History of wound infection
• Malnutrition (serum albumin less than 3.4 g/d)
• Coronary Artery Disease (CAD)
• History of chemotherapy
• Diagnosis of hypertension
• History of malignancy without evidence of active disease
• Renal insufficiency (serum creatinine concentration ≥2.5 mg/d) Pre-Operative Exclusion Criteria Assessed during subject screening:
• Subject is involved in another interventional drug or device study
• Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• Subject has a history of:
• Previous hernia repair involving retrorectus/retromuscular mesh placement or a component separation technique (CST)
• Allergic reactions to products with PLLA/TMC (Poly-L-lactide, poly-trimethylene carbonate copolymer)
• Solid organ transplantation
• Subject has current diagnosis/usage of:
• BMI greater than or equal to 40.0 kg/m2
• Human Immunodeficiency Virus (HIV)
• Collagen formation disorder (such as Ehlers-Danlos syndrome and Marfan's syndrome)
• Liver cirrhosis and/or current ascites
• Renal disease requiring dialysis
• Bleeding disorder and/or cannot be removed from anticoagulants prior to surgery based on surgeon discretion and standard-of-care (excluding aspirin)
• Chronic immunosuppression therapy (10 mg or greater of prednisone or equivalence/ day)
• Current or anticipated chemotherapy/radiotherapy during study period
• Stoma
• Any systemic or local ongoing infection that is uncontrolled and/or requiring treatment such as antimicrobial medication (Note: other uses of antimicrobial medications not excluded)
• Subject has life expectancy of less than 5 years based on the judgement of investigator
• Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)
• Subject is breastfeeding or is planning to breastfeed during the study duration period
• Subject has any other medical condition that precludes the subject from participation, in the opinion of the investigator
• Subject is undergoing:
• Minimally invasive hernia repair (i.e., laparoscopic or robotic surgery)
• An emergency surgery (i.e., lifesaving procedures performed where subject is in imminent danger of death)
• Multi-stage hernia repair
• Parastomal hernia repair
• Concomitant ostomy (creation or closure)
• Any other additional anticipated surgery, if subsequent surgery that would jeopardize previous application of study device, in the opinion of the investigator Pre-Operative Exclusion Criteria assessed/confirmed on day of surgery:
• Subject is American Society of Anesthesiology Class 4, 5, or 6
• Subject has a BMI greater than or equal 40.0 kg/m2
• Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal) Intraoperative Exclusion Criteria Assessed by investigator following reduction of hernia and preparation of the retrorectus/ retromuscular space for mesh placement:
• Subject has existing mesh from previous ventral hernia surgery that investigator was unable to completely remove
• Subject has concomitant diastasis (\>2 cm) that was not repaired
• Hernia defect that will require a multi-stage repair
• Subject no longer meets Inclusion Criteria 4
• Subject who will require more than a single piece of Transorb™ or any other additional mesh
• Subject with anticipated inability to achieve both:
• Midline anterior and posterior rectus fascia closure without excessive tension, and
• Skin closure
• Subject who is otherwise no longer eligible to receive Transorb™ in open retrorectus/retromuscular position with or without Transversus Abdominis Release (TAR).
DEVICE: Transorb™ Self-Gripping Resorbable Mesh
Hernia, Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
Hernia Recurrence, Hernia, Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
I'm interested

Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases

clinicaltrials@northshore.org

ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05438212
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Inclusion Criteria:
* Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration * The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure \> 2.0 cm and \< 5.0 cm. * The maximum diameter of the lesions not to be resected must measure \< 4.0 cm * Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years * All brain metastases must be located \> 5 mm from the optic chiasm and outside the brainstem * Patient is able to medically tolerate surgery and SRS * The lesion chosen for surgical therapy must be deemed an appropriate target for safe, gross total resection by the treating surgeon * History/physical examination within 14 days prior to registration * Age \>= 18 * Karnofsky performance status (KPS) \>= 60 within 14 days prior to registration * A negative urine or serum pregnancy test (in persons of childbearing potential) within =\< 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months * Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria:
* Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site * Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed * Evidence of leptomeningeal disease (LMD) * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion * Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery * Primary histology of germ cell tumor, small cell carcinoma or lymphoma * More than one brain metastasis planned for resection * Inability to undergo MRI with contrast * Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS * Note: chemotherapy and immunotherapy outside of this window are allowed
PROCEDURE: Brain Surgery, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Stereotactic Radiosurgery
Metastatic Malignant Neoplasm in the Brain
I'm interested

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

clinicaltrials@northshore.org

ALL
18 years to 100 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT06527404
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Inclusion Criteria:
* Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years) * Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months. * Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day 1. * Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk. * History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
Exclusion Criteria:
* Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed). * Prurigo nodularis secondary to medications. * Prurigo nodularis secondary to neurologic or psychiatric medical conditions. * Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization. * Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.
DRUG: Rocatinlimab, DRUG: Placebo
Prurigo Nodularis
Rocatinlimab
I'm interested

Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain

clinicaltrials@northshore.org

ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT06500455
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Inclusion/
Exclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration: * Non-small cell lung cancer * Melanoma * Breast cancer * Renal cell carcinoma * Gastrointestinal cancer * If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography \[PET\]/CT, prostate-specific membrane antigen \[PSMA\] PET, etc.) is required * Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration * At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm * All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm. Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator * Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5 * No more than 2 lesions planned for resection if clinically indicated * No known leptomeningeal disease (LMD) * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion * Age ≥ 18 years * Karnofsky performance status (KPS) ≥ 60 * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal * No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \[PCI\]) * New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: 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) * No active infection currently requiring intravenous (IV) antibiotic management * No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy
PROCEDURE: Computed Tomography, RADIATION: Fractionated Stereotactic Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, RADIATION: Stereotactic Radiosurgery
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Breast Carcinoma, Metastatic Digestive System Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
I'm interested

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

clinicaltrials@northshore.org

ALL
2 years to 11 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT06548360
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Inclusion Criteria:
* Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI. * Total body vitiligo area does not exceed 10% BSA. * Pigmented hair within some of the areas of vitiligo on the face. * Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. * For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream.
Exclusion Criteria:
* Diagnosis of other forms of vitiligo (eg, segmental). * Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor). * Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments. * Prior or current use of depigmentation treatments (eg, monobenzone). * Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Use of protocol-defined treatments within the indicated washout period before baseline. * Current or previous use of JAK inhibitors, systemic or topical. * Protocol-defined clinically significant abnormal laboratory values at screening. * BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen. * Pregnant or lactating participants or those considering pregnancy during the period of their study participation. * In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations. * Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study. * Employees of the sponsor or investigator or are otherwise dependents of them. * Known allergy or reaction to any component of the study cream formulation. Other protocol-defined Inclusion/Exclusion Criteria may apply.
DRUG: Ruxolitinib Cream, DRUG: Vehicle Cream
NonSegmental Vitiligo
NonSegmental Vitiligo, pediatric
I'm interested

Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy

Kate Honeyfield - khoneyfield@northshore.org

FEMALE
18 years to 60 years old
NCT06314009
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Inclusion Criteria:
* singleton pregnancy
Exclusion Criteria:
* multifetal gestation * congenital anomaly * claustrophobia, or ineligible for MRI (incompatible implanted medical device)
DIAGNOSTIC_TEST: functional Magnetic Resonance Imaging (fMRI)
Placenta Diseases
Placental Perfusion, Placental oxygenation
I'm interested

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

clinicaltrials@northshore.org

ALL
18 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT06717698
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Inclusion Criteria:
* Female of non-childbearing potential, or male. * For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male. * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus. * HbA1c of 6.5 percentage (%)-10.5 percentage (%) \[48 - 91 millimoles per mole (mmol/mol)\] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (\<)6.5 percentage (%) \[\<48 mmol/mol\] if not diagnosed with type 2 diabetes mellitus. * BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m\^2) at screening. * Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to (≥) 15 and less than (\<) 90 mL/min/1.73 m\^2. * Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (\<) 5000 milligram per gram (mg/g). * Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective non-systemic contraception with low user-dependency. * Lupus nephritis or antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. * Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to enrolment. * Use of any glucagon-like peptide-1 (GLP-1) RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening. * Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening. * Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening. * Only applicable for participants with type 2 diabetes (T2D): Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.
DRUG: NNC0519-0130, DRUG: Placebo, DRUG: Semaglutide
Chronic Kidney Disease
I'm interested

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain (CPMP)

clinicaltrials@northshore.org

ALL
18 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT05986292
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Inclusion Criteria:
* have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening. * have a history of daily pain for at least 12 weeks based on participant report or medical history * have a value of ≤30 on the pain catastrophizing scale * have a body mass index \<40 kilogram/square meter (kg/m²) (inclusive) * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation. * are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study
Exclusion Criteria:
* have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia * have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques) * have surgery planned during the study for any reason, related or not to the disease state under evaluation. * have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. * have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. * have fibromyalgia * have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association) * have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study. * have a positive human immunodeficiency virus (HIV) test result at screening * have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
DRUG: LY3016859 ISA, DRUG: LY3556050 ISA, DRUG: LY3526318 ISA, DRUG: LY3857210 ISA, DRUG: Placebo Oral, DRUG: Placebo
Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain
I'm interested

A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

clinicaltrials@northshore.org

ALL
18 years to 75 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT06046729
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Inclusion Criteria:
* Have a diagnosis of HS for at least 12 months. * Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III. * Have an (abscess plus inflammatory nodule) count of at least 5. * Agree to use topical antiseptics daily. * Had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Exclusion Criteria:
* Have more than 20 draining fistulae. * Have had surgical treatment for HS in the last 4 weeks before randomization. * Have an active skin disease or condition, that could interfere with the assessment of HS. * Have a current or recent acute, active infection. * Are immunocompromised. * Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.
DRUG: Eltrekibart, DRUG: Placebo
Hidradenitis Suppurativa
I'm interested

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

clinicaltrials@northshore.org

ALL
18 years to 65 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT05851443
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Inclusion Criteria:
* Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening. * Pre-BD FEV1 \< 80% predicted according to central over read value at Visit 2. * Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1. * At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening * ACQ-6 ≥ 1.5 at screening.
Exclusion Criteria:
* Maintenance use of asthma controllers other than ICS-LABA. * Have undergone bronchial thermoplasty. * Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * Current conditions or history of other diseases, as follows: * Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction. * Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery. * Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis. * Recipient of an organ transplant that requires continued immunosuppression. * Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). * Any malignancies or history of malignancies. * Chronic or recurrent infectious disease. * Receipt of any biologic drugs used for asthma \< 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening
DRUG: povorcitinib, OTHER: placebo, DRUG: ICS-LABA
Moderate to Severe Asthma
Asthma, Moderate to Severe, INCB54707, Povorcitinib, ICS-LABA
I'm interested

Falcon Real World Evidence Registry

clinicaltrials@northshore.org

ALL
50 years to 80 years old
This study is also accepting healthy volunteers
NCT06589310
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Inclusion Criteria:
* Participant age at time of consent is between 50 and 80 years * Agree to receive the Exact Sciences MCED test and follow-up imaging * Willing and able to provide informed consent * Access to a suitable technology and willing to complete surveys electronically
Exclusion Criteria:
* Any invasive tumor (excluding non-melanoma skin cancers) or hematological malignancy in the previous three years or current suspicion of cancer and/or in active treatment (e.g., chemotherapy, radiation therapy, immunotherapy, and/or surgery
DEVICE: Exact Sciences Multicancer Early Detection (MCED) Test
Cancer
I'm interested

A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight

clinicaltrials@northshore.org

ALL
18 years to 75 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT06683508
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Inclusion Criteria:
W8M-MC-GN01: * Assigned male at birth * Assigned female at birth, who are of non-childbearing potential W8M-MC-CWMM: * Have a BMI ≥27 kilograms per square meter (kg/m²) * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)
Exclusion Criteria:
W8M-MC-GN01: * Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus * Have a history of acute or chronic pancreatitis * Have renal impairment * Individuals who are of childbearing potential W8M-MC-CWMM: * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening. * Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma. * Have poorly controlled hypertension. * Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure. * Have a history of symptomatic gallbladder disease within the past 2 years * Have a lifetime history of suicide attempts.
DRUG: LY3549492, DRUG: Placebo
Obesity, Overweight
I'm interested

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

clinicaltrials@northshore.org

ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT06550076
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Main
Inclusion Criteria:
Part A: * Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator. * Participant has provided written informed consent and any required privacy authorization before the initiation of any study procedures. * Participant is aged 18 years or older at the time of consent. * Participant has a diagnosis of chronic plaque psoriasis for \>=6 months prior to the screening visit. * Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for \>=6 months before screening. * Participant has moderate-to-severe plaque psoriasis as defined by a PASI score \>=12 and a sPGA score \>=3 at screening and Day 1. * Participant has plaque psoriasis covering \>=10% of his or her total BSA at screening and Day 1. * Participant must be a candidate for phototherapy or systemic therapy. Part B:
• Participant has completed 52 weeks of treatment (TAK-279-3001 or Part A) or 60 weeks of treatment (TAK-279-3002) in their parent study or Part A. Main Exclusion Criteria Part A: * Participant has evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary. * Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (e.g., inflammatory bowel disease). * Participant has any clinically significant medical condition, evidence of an unstable clinical condition (e.g., cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results. These include but are not limited to:
• Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
• Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study.
• Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
• Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
• Participant has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
• For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1.
• Participant has any of the following cardiovascular disease history: A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (e.g., pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll.
• Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the investigator.
• Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
• Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by 1) medical history; or 2) by Columbia-Suicide Severity Rating Scale (C-SSRS) documentation at screening or by answering "yes" to Question 5 for suicidal ideation on the C-SSRS at screening; or 3) is clinically deemed to have a suicide risk by the investigator.
• Participant has a patient health questionnaire - 8 (PHQ-8) score of 15 or above at screening.
• Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1. * Participant has received any of the following biologics or biosimilar versions within the time frame indicated or 5 half-lives, whichever is longer:
• Antibodies to interleukin (IL) -12/-23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1.
• Tumor necrosis factor inhibitor(s) (e.g., etanercept, adalimumab, infliximab, certolizumab) within 2 months prior to Day 1.
• Agents that modulate integrin pathways to impact lymphocyte trafficking (e.g., natalizumab) or agents that modulate B cells or T cells (e.g., alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1.
• Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1. * Participant has any previous exposure to TAK-279 (also known as NDI-034858) or other TYK2 inhibitors, including deucravacitinib, or participant participated in any study that included a TYK2 inhibitor (e.g., deucravacitinib, VTX958, GLPG3667, etc.), unless the participant has documentation of post-trial unblinding that confirms the partcipant did not receive a TYK2 inhibitor. * Participant has a known or suspected allergy to TAK-279 or any of its components. Part B: * Participant has completed the parent study or Part A but was permanently discontinued from treatment. * Participant had evidence of significant noncompliance with study visits or study drug in the parent study or Part A, as defined in the parent study protocol or in the opinion of the investigator. * Participant has met criteria for termination from the parent study or Part A, regardless of whether or not the participant was terminated from the parent study or Part A. * Participant has developed evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis) since enrollment in the parent study or Part A. * Participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments. * Participant has received a prohibited psoriasis treatment during the parent study or Part A, whether or not that treatment was documented as a concomitant medication and is expected to continue that treatment.
DRUG: TAK-279
Plaque Psoriasis
Latitude Psoriasis 3, Latitude Research Program, Latitude PsO OLE
I'm interested

Letrozole in Uterine Leiomyosarcoma

clinicaltrials@northshore.org

FEMALE
18 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT05649956
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Inclusion Criteria:

• Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.
• Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission of pathology report documenting uterine leiomyosarcoma histology is required in the IRT Source Document Portal following randomization.
• Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of ER status testing in the IRT Source Document Portal.
• Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.
• All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI.
• Patients must have an ECOG performance status of 0, 1, or 2.
• Patients must have adequate organ and marrow function as defined below: NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marrow function: * Absolute neutrophil count (ANC) greater than or equal to 1500 cells/mcl * Platelet count greater than or equal to 100,000 cells/mcl * Hemoglobin greater than or equal to 9.0 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the Investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion). Renal function: • Serum creatinine less than or equal to 1.5 x ULN Hepatic function: * AST (aspartate aminotransferase) and ALT (alanine aminotransferase) less than or equal to 3.0 x ULN * Serum albumin greater than or equal to 2.5 g/dL
• Patient must be at least 18 years of age.
• Patient must be able to swallow oral medication.
Exclusion Criteria:
Exclusion Criteria 1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors are permitted).
• Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
• Patients with concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
• Patients who have a history of taking any aromatase inhibitor within the past 5 years.
• Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled hypertension (defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm HR despite antihypertensive medications), unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure (NYHA Class II or greater), clinically significant cardiac arrhythmias, and cardiomyopathy with an ejection fraction under 40%.
• Patients currently receiving chemotherapy or radiation therapy. 8. Patients with severe hepatic impairment and/or cirrhosis. 9. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication.
• Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.
• Patients with known hypersensitivity to any of the excipients of letrozole. 12. Patients who are pregnant or breast-feeding. 13. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days of prior to enrollment.
• Patients currently using systemic estrogens, including herbals and supplements with estrogenic properties. The use of vaginal estrogen is permitted if symptoms are refractory to moisturizers and lubricants.
DRUG: Letrozole
Uterine Leiomyosarcoma
I'm interested

National Cancer Institute "Cancer Moonshot Biobank"

clinicaltrials@northshore.org

ALL
13 years and over
This study is NOT accepting healthy volunteers
NCT04314401
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Inclusion Criteria:
* Is consistent with OR has been diagnosed with one of the following: * Colorectal cancer: Stage IV * Non-small cell or small cell lung cancer: stage III/IV * Prostate cancer: metastatic prostate cancer * Gastric cancer, not otherwise specified (NOS): stage IV * Esophageal cancer, NOS: stage IV * Adenocarcinoma of gastroesophageal junction: stage IV * High grade serous ovarian cancer: stage III/IV * Invasive breast carcinoma: stage III/IV * Melanoma: stage III/IV * Acute myeloid leukemia * Multiple myeloma * For the purposes of this study, re-staging is allowed * Patient should fit in one of the following four clinical scenarios (a-d) * Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR * Scheduled to begin treatment with a new regimen of standard of care therapy OR * Currently progressing on a regimen of standard of care therapy OR * Currently being treated with a regimen standard of care therapy, without evidence of progression * Requirements for fresh tissue biospecimen collections at enrollment: * For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment * For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy * For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure * For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR * The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling * Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state * Requirements for archival tissue: * For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE * For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED * Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that: * Contains the cancer type for which the participant is enrolled, and * Was collected no more than 5 years prior to initiation of therapy, and * Contains at least a surface area of 5 mm\^2 and optimum surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and * No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy * Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment * Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection * Blood collection for clinical scenario d must take place within 4 weeks of enrollment * Age 13 or older * Any sex and any gender * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 * Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)
Exclusion Criteria:
* Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial * Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy * Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion * Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use * Factor X inhibitors are permitted * Use of anti-platelet drugs are permitted * Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP) * NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) * NCI PDMR EXCLUSION CRITERIA: Patients with complete response * NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections * NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection * Actively febrile patients with uncertain etiology of febrile episode * All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics * NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution
PROCEDURE: Biospecimen Collection, OTHER: Medical Chart Review
Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Lung Non-Small Cell Carcinoma, Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Metastatic Prostate Carcinoma, Multiple Myeloma, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
I'm interested

A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Monotherapy Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (ESTUARY)

clinicaltrials@northshore.org

ALL
12 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT06407934
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Inclusion Criteria:
* Participants must be at least 12 years of age inclusive, at the time the informed consent is signed. * Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD. * Able and willing to comply with requested study visit and procedures. * Body weight must be ≥ 25 kg.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply: * Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols. * Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE). * Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant. * Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study. * Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.). * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
DRUG: Amlitelimab, DRUG: Placebo
Dermatitis Atopic
I'm interested

A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)

clinicaltrials@northshore.org

ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT06586112
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Inclusion Criteria:

• Males or females, age ≥18 years
• Diagnosis of plaque psoriasis for ≥6 months
• Plaques covering ≥10% of BSA
• PASI ≥12
• sPGA ≥3
• Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
Exclusion Criteria:

• Nonplaque psoriasis or other inflammatory skin conditions
• immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Participants with psoriatic arthritis may participate
• Pregnant, lactating, or planning to get pregnant during the study
• Use of drugs prior to Study Day 1 that treat or may affect psoriasis: * Topical within 2 weeks * Phototherapy or any systemic treatments within 4 weeks * Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFα inhibitor within 2 months, or IL-17 within 4 months * Systemic immunosuppressants or immunomodulatory drugs within 4 weeks * Modulators of B cells within 6 months, or T cells within 3 months * JAK inhibitors or TYK2 inhibitors within 4 weeks * PDE4 inhibitor within 2 months * Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study
• Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
• Participants with QTcF \>450 msec (males) or \>470 msec (females) at Screening
• Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
• Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
• Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
• History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
• Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
• History of any immune-mediated or inflammatory medical condition for which participants requires current systemic corticosteroids \* Stable doses of inhaled corticosteroids for treatment of asthma are allowed
• Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
• Live vaccines within 4 weeks prior to Study Day 1
• Participant has planned surgery during the study period
• Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the participant if he or she participates in the study
• History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening
• Evidence of severe depressive symptoms or active suicidal ideation or behavior
DRUG: ESK-001, DRUG: Apremilast, DRUG: Placebo
Plaque Psoriasis
I'm interested

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (EMBARQ-CSU1)

clinicaltrials@northshore.org

ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT06445023
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Key
Inclusion Criteria:

• Males and females, \>/= 18 years of age.
• Diagnosis of chronic spontaneous urticaria (CSU) \>/= 6 months.
• CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
• The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
• Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
• UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to treatment.
• Normal blood counts and liver function tests.
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.
• Participants with and without prior biologic experience are eligible. Key
Exclusion Criteria:

• Women who are pregnant or nursing.
• Chronic inducible urticaria that would confound the study endpoints.
• Other diseases associated with urticaria.
• Active pruritic skin condition in addition to CSU.
• Medical condition that would cause additional risk or interfere with study procedures.
• Known HIV, hepatitis B or hepatitis C infection.
• Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
• History of anaphylaxis
• Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
BIOLOGICAL: barzolvolimab, BIOLOGICAL: Matching placebo
Chronic Spontaneous Urticaria
CDX-0159, barzolvolimab, chronic spontaneous urticaria, CSU, urticaria activity score, itch severity score, hives severity score
I'm interested

TRIcvalve BiCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) (TRICAV-I)

clinicaltrials@northshore.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT06137807
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Inclusion Criteria:

• Subject must be 18 years or older, at the time of signing the informed consent.
• Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
• NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
• Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.
• The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
• For females of childbearing potential, negative pregnancy test.
• Capable of giving signed informed consent.
Exclusion Criteria:

• Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.
• Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction.
• LVEF ≤ 30% on echocardiography.
• Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
• Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 \[at least 0.75 if BMI \>30 kg/m2\], DVI \<2.2, mean gradient \<5mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild \[1+\]) or acceptable (≤ moderate \[2+\]).
• Severe right ventricular dysfunction.
• Cardiac amyloidosis
• Pulmonary artery systolic pressure (PASP) \>65 mmHg assessed with Echo Doppler and /or right heart catheterization.
• Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
• Hemodynamically significant pericardial effusion.
• Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure)
• Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
• Unable to tolerate anticoagulation/antiplatelet therapy
• Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
• Any known life-threatening condition with an estimated life span of at least 12 months.
• Platelet count \< 75,000/mm3
• Child-Pugh Severity Class C (10-15 points).
• Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.
• Endocarditis or active/ongoing infection requiring antibiotics.
• Unable to walk at least 60 meters in a 6minute walk test.
• Known bleeding or clotting disorders or patient refuses blood transfusion.
• Active gastrointestinal (GI) bleeding within 3 months of randomization.
• Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
• Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.
• Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.
• Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up
• Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.
DEVICE: TricValve® Transcatheter Bicaval Valve System
Tricuspid Regurgitation, Tricuspid Valve Disease
Tricuspid Regurgitation, Heart Failure
I'm interested

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

clinicaltrials@northshore.org

ALL
18 years to 59 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT05554406
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Inclusion Criteria:
* STEP 1 REGISTRATION: * 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, prior to registration to this study. * Note: Pre-enrollment/diagnosis labs must have already been performed under the MYELOMATCH * Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria * Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria * Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible * Acute promyelocytic leukemia is excluded * Participants with favorable or intermediate risk disease are excluded * Participants with FLT3 mutations (ITD or TKD) are excluded * Participants with t(9;22) translocation are excluded * A single dose of intrathecal chemotherapy is allowed prior to study entry * Prior anthracycline therapy is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent. Prior hypomethylating agent (HMA) exposure is allowed, as long as not for AML diagnosis * Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed. * Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy * Participants must be between 18 and 59 years of age * Participants must have Zubrod performance status =\< 3 as determined by a history and physical (H\&P) completed within 14 days prior to registration * Participants must have a complete medical history and physical exam within 7 days prior to registration * Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months prior to registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration * The following tests must be performed within 14 days prior to registration to establish baseline values: * Complete blood count (CBC)/differential/platelets * Total bilirubin * Lactate dehydrogenase (LDH) * Albumin * Glucose * Fibrinogen * Participants must have adequate kidney function as evidenced by creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration * Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN), and total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration * Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration * Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction \>= 50% within 28 days prior to registration * Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy * Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded * Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives \[examples include birth control pills, vaginal rings, or patches\] associated with inhibition of ovulation for at least 1 month prior to taking study drug), "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. However, if at any point a previously celibate participant 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. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown * Participants must have agreed to have specimens submitted for translational medicine (MRD) under the myeloMATCH MSRP and specimens must be submitted * 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 * 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
DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, PROCEDURE: Echocardiography, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, PROCEDURE: Multigated Acquisition Scan, DRUG: Venetoclax
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia, Myelodysplasia-Related
I'm interested

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

clinicaltrials@northshore.org

ALL
18 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT06585150
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Key
Inclusion Criteria:
* Exhibits at least 1 of the following risk factors for severe RSV disease:
• Age ≥ 60 years
• Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
• Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
• One or more of the following chronic lung diseases: * i) Bronchiectasis * ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis) * iii) Pulmonary hypertension
• Chronic cardiovascular disease exclusive of hypertension * RSV infection confirmed ≤ 3 days before randomization * New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity a screening, and onset ≤ 3 days before randomization. * RSV vaccine status: * Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV. Key
Exclusion Criteria:
* Currently requiring or expected to require hospitalization within 48 hours after randomization. * Documented previous infection and/or hospitalization for RSV during the current respiratory virus season. * Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization. * Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization. * Individuals with a history of cystic fibrosis. * Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization. * Pregnant at screening. * Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV \< 28 days or \< 5 half-lives, whichever is longer, before randomization. * Received an investigational product \< 28 days or \< 5 half-lives, whichever is longer, before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: Obeldesivir, DRUG: Obeldesivir Placebo
RSV Infection
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MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

clinicaltrials@northshore.org

ALL
18 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT05564390
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Inclusion Criteria:
* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS. * Participants must be \>= 18 years of age. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. * Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure. * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment. * Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy * Note: active hormonal therapy is allowed * Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration. * Participants must agree to have translational medicine specimens submitted. * Participants must be offered the opportunity to participate in specimen banking. * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP. * 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. * 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. * The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.
DRUG: Azacitidine, OTHER: Best Practice, PROCEDURE: Biopsy, PROCEDURE: Biospecimen Collection, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine and Cedazuridine, PROCEDURE: Echocardiography, DRUG: Enasidenib, DRUG: Gilteritinib, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Venetoclax
Acute Myeloid Leukemia, Myelodysplastic Syndrome
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A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events (TRANSFORM)

clinicaltrials@northshore.org

ALL
55 years and over
NA
This study is also accepting healthy volunteers
NCT06112418
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Inclusion Criteria:

• Provided electronic or written informed consent
• Men \> 55, women \> 65 years of age
• Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recent HbA1c 5.7 to 6.4% and/or fasting glucose 100-125 mg/dL \[5.6-6.9 mmol/L\]) and/or metabolic syndrome. Metabolic syndrome is defined as \> 3 of the following criteria (International Diabetes Federation 2006): * Body mass index ≥ 27 kg/m2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches) * Fasting triglycerides ≥ 150 mg/dL (1.7 mmol/L) or treated hypertriglyceridemia * HDL-cholesterol (HDL-C) \< 40 mg/dL (1.03 mmol/L) in men, \<50 mg/dL (1.29 mmol/L) in women or treatment for this lipid abnormality * Systolic blood pressure (BP) ≥ 130 and/or diastolic BP≥ 85 mm Hg and/or treated hypertension * Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or HbA1c ≥ 5.7%
• Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group
Exclusion Criteria:

• History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure
• Planned arterial revascularization
• Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:
• eGFR \< 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org/professionals/kdoqi/gfr_calculator)
• Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.
• Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
• Weight \> 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site
• Inability to hold breath for \> 10 seconds
• Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \> 80 beats per minute at screening or prior to CCTA)
• Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA
• Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA
• Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. ≥ 70%; site will be notified by Cleerly), other health condition with life expectancy \< 3 years or being at risk of poor compliance with study procedures (e.g., active substance abuse or untreated mental illness that, in the opinion of the investigator, is likely to adversely affect adherence or retention)
DEVICE: The Cleerly CAD Staging System
Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome
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Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

clinicaltrials@northshore.org

MALE
18 years and over
PHASE4
This study is NOT accepting healthy volunteers
NCT06604442
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Inclusion Criteria:
* Male ≥18 years of age at Visit 1 (Screening). * Documented history of localized adenocarcinoma of the prostate with prior curative intent treatment with RP and undetectable PSA post-surgery, experiencing BCR of prostate cancer. * At least 6 months must have elapsed after RP. * Low PSA BCR defined as PSA ≤0.5 ng/mL. * Scheduled by their treating physician to receive a PSMA (18F) PET scan. * Written informed consent obtained from the patient and ability for the patient to comply with the requirements of the study.
Exclusion Criteria:
* Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements. * Patients who are planned to have an x-ray contrast agent or any other PET radiotracer within 24 hours prior to either PSMA PET scan. * Patients who have already received a piflufolastat (18F) PET scan prior to providing informed consent for this study. * Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to either of the PSMA PET scans in this study. * Patients with known hypersensitivity to the active substance or to any of the excipients of piflufolastat (18F) or flotufolastat (18F). * Patients who have previously undergone a cystectomy or have renal failure, or have other conditions that may significantly affect urinary output, as judged by the investigator. * Patients who have already received salvage therapy.
DRUG: Flotufolastat (18F), DRUG: piflufolastat (18F)
Prostate Cancer
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SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial (SEAL™IT)

clinicaltrials@northshore.org

ALL
22 years to 80 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05831202
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Inclusion Criteria:

• 22 to 80 years of age at the time of screening.
• Unruptured aneurysm requiring endovascular treatment suitable for SEAL device and meet the American Heart Association (AHA) guidelines for management of unruptured aneurysm.5
• Ruptured aneurysm A ruptured aneurysm is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of Subarachnoid Hemorrhage (SAH) attributed to the index aneurysm within the last 60 days. Ruptured aneurysm may be included according to the following criteria: The subject is neurologically stable with no seizure at the onset of the SAH, not requiring External Ventricular Drain (EVD) placement prior to inclusion. * Hunt and Hess scale (HHS) of 2 or less at the time of treatment. * mRS of ≤2 prior to presentation or aneurysm rupture. * Meet the AHA guidelines for management of ruptured aneurysm.
• The index intracranial aneurysm (IA) to be treated must include the following features: * Group A (primary analysis group): The Terminus/ bifurcation location: * 2 mm to 19 mm in equatorial aneurysm width wide neck aneurysm: * Absolute neck size ≥ 4mm and \< 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2 * Saccular morphology * Located in the anterior or posterior circulation * Group B (Expanded Indication): The Sidewall location: * 2 mm to 19 mm in equatorial aneurysm width wide neck aneurysm: * Absolute neck size ≥ 4mm and \< 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2 * Saccular morphology * Located in the anterior or posterior circulation
• Aneurysm treatment does not require the preplanned use of any additional implanted devices.
• Subject is able to maintain compliance with all aspects of screening, evaluation, treatment, and post-procedure follow-up schedule.
• Baseline pre-procedure mRS of 0-2 for unruptured aneurysm and 0-2 prior to the SAH for the ruptured aneurysms.
• Ability to obtain written informed consent document (ICD) subject or legally authorized representative in SAH subjects prior to the initiation of any study procedures.
Exclusion Criteria:

• Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
• Aneurysms smaller than 2 mm and larger than 19 mm in dome width.
• Patients with untreated multiple aneurysms \[≥2mm\]. Patient with multiple aneurysms, should have the none index aneurysms treated no less than 60 days prior to enrollment in the SEAL™ IT trial, ≤ 7mm, and not treated with flow diverter or stent assisted endovascular therapy.
• Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, proximal or intracranial vessel tortuosity or poor aneurysm angle take-off.
• Patients with two 360 degrees loops in the carotid or vertebral arteries.
• Presence of vascular disease or other vascular abnormality that could prohibit access to index aneurysm such carotid stenosis or diminished caliber of the target artery.
• Clinical, angiographic, or CT evidence of central nervous system (CNS) arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma \< 3 cm), or any other intracranial vascular malformations.
• Patients with high risk for recurrent ischemic stroke due to previous history of ischemic stroke symptoms such as TIAs, minor, or major strokes within the past 60 days. Other stroke risk factors such as intracranial stenosis or atrial fibrillation.
• Patients with hemodynamic or medical compromise due to medical comorbidities such as severe unstable congestive heart failure (ejection fraction \<30%) or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.
• Target index aneurysm that has been previously treated and contains devices, implants, or coils that could interfere with correct SEAL™ device placement.
• Subject is pregnant or a lactating female (For females of child-bearing potential, a positive pregnancy test within 7 days of the day of procedure or refusal to use a medically accepted method of birth control for the duration of the study.
• Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
• Currently enrolled in another investigational study or post-market study that could affect the safety and efficacy of aneurysm treatment or interfere with the study follow-up schedule.
• Presence of an acute life-threatening illness requiring treatment.
• Life expectancy of \< 5 years.
• Subject has an uncontrolled co-morbid medical, neurological, or psychiatric condition, that would adversely affect participation in the study procedures and follow up.
• Patient with chronic kidney disease (and not on dialysis) with creatinine \> 2.0.
• Subject with a known, uncontrolled hypersensitivity to iodine-based contrast dye, procedure related materials or medications, or device components\^
• Subject is a prisoner or member of other vulnerable population.
• The subject that is in the opinion of the treating interventionalist is not suitable for the study.
• Subjects with history of intracranial bleeding (SAH, SDH or ICH) within 90 days of the index aneurysm treatment. * Sensitivity to nickel is not specifically excluded, GTI performed ASTM F2129 testing recommended by the FDA in its 2015 and 2019 guiding documents. GTI results from the testing indicated that SEALTM meets the acceptance criteria that there is a high probability that the margin of safety against pitting (Eb-Er) is 200mV or higher, therefore, with high confidence, no further testing is required. The IFU contains the following precaution: "For patients with known hypersensitivity or allergic reaction to the implant components such as titanium or to nickel, use of the SEALTM System may lead to allergic reaction and user should counsel the patient on the device components".
DEVICE: The SEAL™ Saccular Endovascular Aneurysm Lattice System
Intracranial Aneurysm
Interventional Neurology, Intrasaccular Flow Diversion
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Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection (PHINDER)

clinicaltrials@northshore.org

ALL
18 years and over
This study is NOT accepting healthy volunteers
NCT05776225
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Inclusion Criteria
• Patient gives voluntary written informed consent to participate in the study.
• Patients with a diagnosis of ILD based on computed tomography imaging, including:
• Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
• Connective tissue disease-associated ILD with forced vital capacity (FVC) \<70%
• Hypersensitivity pneumonitis
• Scleroderma-related ILD
• Autoimmune ILD
• Nonspecific interstitial pneumonia
• Occupational lung disease
• Combined pulmonary fibrosis and emphysema
• Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the study protocol. Exclusion Criteria
• Prior RHC with mPAP \>20 mmHg.
• Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension medication.
• Diagnosed with chronic obstructive pulmonary disease.
• Uncontrolled or untreated sleep apnea.
• Pulmonary embolism within the past 3 months.
• History of ischemic heart disease or left-sided myocardial dysfunction within 12 months of Screening, defined as left ventricular ejection fraction \<40% or pulmonary capillary wedge pressure \>15 mmHg.
• Any other clinical features that, in the opinion of the Investigator, might adversely affect interpretation of study data or study safety, or make the patient unsuitable for RHC.
PROCEDURE: Right heart catheterization (RHC)
Interstitial Lung Disease, Pulmonary Hypertension
ILD, PH, PH-ILD
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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

clinicaltrials@northshore.org

ALL
18 years to 100 years old
NA
This study is NOT accepting healthy volunteers
NCT05896189
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Inclusion Criteria:
* The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information. * The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III. * The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a. * Participants with greater than or equal to 6 months to 5 years post-treatment (completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) except may still be taking endocrine therapy or HER2-directed adjuvant therapy. * The participant must be able to understand, speak, read, and write in English or Spanish.
Exclusion Criteria:
* Scoring less than or equal to 3 on the 6-item cognitive screen. * Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3. * Definitive clinical or radiologic evidence of metastatic disease. * Prior history of past or current other cancer, except for non-melanoma skin cancer or in situ cervical cancer within the past 5 years. * Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis). * Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery. * Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia. * Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.
BEHAVIORAL: Arm 1: Computerized Cognitive Training-Global Stimulation Games, BEHAVIORAL: Arm 2: Computerized Cognitive Training-Neuroplasticity Games
Breast Cancer, Cognitive Impairments
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Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants

clinicaltrials@northshore.org

FEMALE
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT06575192
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Inclusion Criteria:
* Participants who will undergo unilateral or bilateral mastectomy upon enrollment. * Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.
Exclusion Criteria:
* Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy. * Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.
DEVICE: ARTIA Reconstructive Tissue Matrix, OTHER: No Intervention
Breast Reconstruction
Breast Reconstruction, ADORA, ARTIA
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