Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD (OPTIS)
clinicaltrials@northshore.org
ALL
18 years to 60 years old
NA
This study is NOT accepting healthy volunteers
NCT05566769
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Inclusion Criteria:
* Aged over 18 years old
* NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
* With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)
* EDSS =\< 7
* With no evidence of relapse in the past 3 months before enrollment
* Who have read the information sheet and signed the informed consent form
* Able to use a smartphone
* Owns a personal smartphone which version is above 13 for IOS and 8 for Android included
* Able to read language in which the mobile application is available and able to understand pictograms
Exclusion Criteria:
* Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning
* Pregnant and nursing women
* Person under guardianship or curatorship
* Bedridden patients or patients with a daily activity of less than 2 hours per day
* Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
* Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation (JANUS)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT05610163
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Inclusion Criteria:
* Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
* Tumor site: Rectum; =\< 12cm from the anal verge
* No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
\* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =\< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for \>= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for \>= 6 months after the last treatment
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm
* Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min
\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
* No upper rectal tumors (distal margin of tumor \> 12 cm from the anal verge)
* No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
* No known mismatch repair deficient rectal adenocarcinoma
* Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study \* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
Locally Advanced Rectal Carcinoma, Stage II Rectal Cancer AJCC V8, Stage III Rectal Cancer AJCC V8
I'm interested
Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis
Auddie Sweis, MD - asweis@northshore.org
All
18 years and over
Phase 4
This study is also accepting healthy volunteers
NCT05626621
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Inclusion Criteria:
• Adults 18 years and older seeking treatment for chronic rhinitis and willing to
undergo six months of topical therapy.
• Diagnosis of Chronic Rhinitis.
Exclusion Criteria:
• The patient has diagnosis(es) other than chronic rhinitis that can account for his/her
symptoms (septal deviation, nasal valve collapse, chronic sinusitis).
• Use of oral antihistamines or oral steroids, unless patient undergoes a 4 week washout
period.
• Smokers (tobacco, marijuana, vaping, etc.).
• Known or suspected pregnancy, or lactation.
• Other medical conditions that the investigator believed would confound the study.
• Allergy to study drugs.
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
clinicaltrials@northshore.org
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05633602
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Inclusion Criteria:
• Participants must have histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) which is stage IV or recurrent
• Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy
for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in
combination with other therapy
• Participants must have experienced disease progression (in the opinion of the treating
physician) more than (>) 84 days following initiation (cycle 1 day 1) of their most
recent anti-PD-1 or PD-L1 therapy
• Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent
disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable,
partial response or complete response (in the opinion of the treating physician)
• Participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or
anti-PD-L1 therapy as their only line of anti-PD-1 or anti-PD-L1 therapy must have
experienced disease progression within (=<) 365 days from initiation (cycle 1 day 1)
of anti-PD-1 or PD-L1 therapy
• Participants must have received platinum-based chemotherapy and experienced disease
progression (in the opinion of the treating physician) during or after this regimen
• Participants with a known sensitizing mutation for which an Food and Drug
Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK,
ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously
received at least one of the approved therapy(s). Prior targeted therapy for
participants with targetable alterations is allowed if all other eligibility criteria
are also met
• Participants must be >= 18 years old
• Participants must be able to safely receive the investigational drug combination and
the investigator's choice of standard of care regimens per the current FDA approved
package insert(s), treating investigator's discretion, and institutional guidelines
• Participants must have Zubrod performance status of 0-2
Exclusion Criteria:
• Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for
stage IV or recurrent disease
• Participants must not be receiving or planning to receive another investigational
therapy during study participation
Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
I'm interested
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05633654
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Key
Inclusion Criteria:
* Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
* TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) \< 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
* Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
* Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.
* Adequate organ function.
Key
Exclusion Criteria:
* Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
* Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior or concurrent treatment with any endocrine therapy agent.
* Evidence of recurrent disease following preoperative therapy and surgery.
* Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
* Individuals with germline breast cancer gene (BRCA) mutations.
* Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of \< 50%
* Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids (VAYHIT2)
clinicaltrials@northshore.org
ALL
18 years to 100 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05653219
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Key Inclusion criteria
• Male or female patients aged 18 years and older on the day of signing the informed consent.
• A signed informed consent must be obtained prior to participation in the study.
• A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
• Patient with platelet count \<30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag
Key Exclusion criteria
• ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
• Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia, (patients with low grade anemia related to bleeding or iron deficiency are eligible).
• Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
• Patients with current or history of life-threatening bleeding
• Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
• Patients with known active or uncontrolled infection requiring systemic treatment during screening period
• Patients with hepatic impairment
• Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
• Nursing (breast feeding) or pregnant women
Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
clinicaltrials@northshore.org
ALL
5 years to 60 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05675410
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Inclusion Criteria:
* Patients must be 5 to 60 years of age at the time of enrollment
* Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease
* Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
* Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
* Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.
* Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.
* Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
* Patients =\< 17 years of age must have a Lansky performance score of \>= 50
* Pediatric patients (age 5-17 years): A serum creatinine based on age/gender as follows (within 28 days prior to enrollment):
* 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
* 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
* 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
* 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
* \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
* Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)
* Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air
* Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
* Patients with nodular lymphocyte predominant Hodgkin lymphoma
* Patients with a history of active interstitial pneumonitis or interstitial lung disease
* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment
* Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease
* Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
* Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
* Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
* Prior solid organ transplant
* Prior allogeneic stem cell transplantation
* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
* Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin
* Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
clinicaltrials@northshore.org
ALL
12 years to 17 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05677451
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Key
Inclusion Criteria:
* Male and female adolescent participants aged \>= 12 to \< 18 years of age at the time of signing the informed consent
* CSU duration for \>= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation)
* Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as:
* The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines
* UAS7 score (range 0 - 42) \>= 16, ISS7 score (range 0 - 21) \>= 6 and HSS7 score (range 0 - 21) \>= 6 during the 7 days prior to randomization (Day 1)
* Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants' medical history)
Key Exclusion criteria:
* Previous use of remibrutinib or other BTK inhibitors
* Significant bleeding risk or coagulation disorders
* History of gastrointestinal bleeding
* Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited
* History or current hepatic disease
* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant
* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes
* Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
* Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria
* Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
Other protocol-defined inclusion/exclusion criteria may apply.
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic NOH in Participants with Multiple System Atrophy (CYPRESS)
clinicaltrials@northshore.org
ALL
30 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05696717
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Inclusion Criteria:
* Participant is male or female and at least 30 years old.
* Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).
* Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) confirmed by the Enrollment Steering Committee (ESC).
* Participant must meet the diagnostic criteria of nOH, as demonstrated by a sustained reduction in BP of ≥20 mmHg (systolic) or ≥10 mmHg (diastolic) within 3 min of standing as part of orthostatic standing test or being tilted up ≥60o from a supine position as determined by a tilt-table test.
* Participant must score ≤4 on UMSARS Part IV at Visit 1 (Screening).
* Participant must score at least a 4 on the OHSA item 1 at Visit 2 (Day 1).
* Participant must be willing to not take any prohibited medications during the study.
* If participant is female, the participant must not be pregnant, breastfeeding, or planning a pregnancy during the course of the study. A woman of childbearing potential must have a documented negative pregnancy test at screening.
* During the study and for 30 days after receiving the last dose of the study drug, females of childbearing potential or males capable of fathering children must agree to use highly effective birth control measures (failure rate \<1% when used consistently and correctly) or agree to abstain from sexual intercourse.
* Participant is willing and able to provide signed and dated written informed consent to -participate prior to initiation of any study related procedures.
Participant is able to communicate well with the Investigator and clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions.
Exclusion Criteria:
* Participant has a systemic illness known to produce autonomic neuropathy, including, but not limited to, amyloidosis and autoimmune neuropathies. Participant with diabetes mellitus (DM) will be evaluated on a case-by-case basis by the medical monitor and considered ineligible unless they meet all of the following criteria:
* Well controlled type-2 DM in treatment with only oral medications and diet
* HbA1C of ≤7.5% performed during screening or up to 12 weeks before screening
* No clinically evident peripheral neuropathy (e.g., normal sensory examination on peripheral extremities)
* No known retinopathy (e.g., annual ophthalmic exam is sufficient)
* No nephropathy (e.g., absence of albuminuria and GFR \>60).
* Participant has a known intolerance to other NRIs or SNRIs.
* Participant currently uses concomitant antihypertensive medication for the treatment of essential hypertension.
* Participant has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half lives, whichever is longer, prior to Visit 2 (Day 1) or requires concomitant use until the Safety follow-up Visit.
* Participant has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to Visit 2 (Day 1).
* Midodrine and droxidopa (if applicable) must be tapered off and stopped at least 7 days prior to Visit 2 (Day 1).
* Participant has known or suspected alcohol or substance abuse within the past 12 months (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM IV TR®\] definition of alcohol or substance abuse).
* Participant has clinically unstable coronary artery disease or had a major cardiovascular event (e.g., myocardial infarction) in the past 6 months.
* Participant has significant uncontrolled cardiac arrhythmia, history of complete heart block, or significant QTc prolongation (≥450 msec for males and ≥470 msec for females).
* Participant has a new onset of a neurological event (i.e., seizures, confusion, altered levels of consciousness, etc.) in the past 6 months.
* Participant has used any monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 (Day 1).
* Participant has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the participant.
* Participant has a Montreal Cognitive Assessment (MoCA) \<21.
* Participant is unable or unwilling to complete all protocol specified procedures including questionnaires.
* Participant has known congestive heart failure (New York Heart Association \[NYHA\] Class 3 or 4).
* Participant has had any malignant disease, other than carcinoma in situ of the cervix or basal cell carcinoma, within the past 2 years prior to Screening.
* Participant has a known gastrointestinal (GI) condition, which in the Investigator's judgment, may affect the absorption of study medication (e.g., ulcerative colitis, gastric bypass).
* Participant has psychiatric, neurological, or behavioral disorders that may interfere with the cognitive ability of the participant to give informed consent, understand and comply with study procedures, or interfere with the conduct of the study.
* Participant is currently receiving any investigational drug or has received an investigational drug within 30 days of dosing. An investigational drug is defined as a drug that is not approved by a regulatory agency (e.g., Food and Drug Administration \[FDA\]).
* Participant has a clinically significant abnormal laboratory finding(s) (e.g., alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] ≥3.0 x upper limit of normal \[ULN\]; blood bilirubin \[total\] ≥3.0 x ULN; estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or any abnormal laboratory value that could interfere with safety of the participant).
* Participant has demonstrated lifetime suicidal ideation and/or suicidal behavior, as outlined by the C-SSRS (Baseline/Screening Version). Participant should be assessed by the rater for risk of suicide and the participant's appropriateness for inclusion in the study.
* Participant has a concurrent disease or condition (e.g., COVID-19), or recent surgery, that in the opinion of the Investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or absorption of the study drug.
* Participant has known hypersensitivity to ampreloxetine (ampreloxetine hydrochloride), or any excipients in the formulation.
* Major surgery (i.e., procedures involving higher risk for infection and extended recovery period, such as, joint replacement, gastric bypass, open heart surgery, organ transplant, etc.) occurring less than 4 weeks prior to enrollment.
DRUG: Ampreloxetine, DRUG: Placebo
Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy
I'm interested
A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting (ARTISTYK)
clinicaltrials@northshore.org
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05701995
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Inclusion Criteria
• Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable
psoriasis is defined as no morphology changes or significant flares of disease
activity in the opinion of the investigator.
• Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
• ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1
• Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1
• Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment
(s-PGA) ≥ 3 at the Screening Visit and Day 1
Exclusion Criteria:
Target Disease Exceptions:
• Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only
involvement or drug-induced psoriasis) at Screening Visit or Day 1
Other protocol-defined inclusion/exclusion criteria apply.
Drug: Deucravacitinib, Other: Placebo
Psoriasis
plaque psoriasis, deucravacitinib, BMS-986165, Health related quality of life (HrQoL), QoL (quality of life), SOTYKTU
I'm interested
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE (LIBREXIA-STROK)
clinicaltrials@northshore.org
ALL
40 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05702034
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Inclusion Criteria:
* Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (\<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (\>=) 6
* Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
* Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
* A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
* Willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria:
* Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (\>) 1 year prior with adequate treatment
* The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
* The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial \[TOAST\] Other Determined Etiology), based on local standard-of-care investigations
* Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
* Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
* Known allergies, hypersensitivity, or intolerance to milvexian or its excipients
DRUG: Milvexian, DRUG: Placebo
Ischemic Stroke, Ischemic Attack, Transient
I'm interested
A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy (ALMOND)
clinicaltrials@northshore.org
ALL
18 years to 75 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT05707377
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Inclusion Criteria:
* Biopsy-confirmed PMN within 5 years before the initial screening (ie, the day the informed consent is signed)
* UPCR (based on 24-hour urine collection) \> 3.5 at initial screening and at confirmation assessment
* Treatment with a maximally tolerated or allowed dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) for ≥ 24 weeks before randomization (12 weeks before initiation of study drug for Part 1) and with adequate blood pressure control (blood pressure \< 130/80 mmHg, measured on ≥ 2 occasions \[not on the same day\] within 4 weeks before the assignment of study treatment)
* Anti-PLA2R antibody \> 50 RU/mL at confirmation assessment (Part 1 only)
Exclusion Criteria:
* Participants with a secondary cause of membranous nephropathy
* Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening
* Severe renal disease as determined by rapid decline in eGFR (defined as \> 15 mL/min/1.73m\^2 within 24 weeks prior to randomization, not otherwise explained)
* A known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infections
* Patients at risk for tuberculosis at screening
* Known infection with serologic status reflecting active or chronic hepatitis B virus infection, or presence of hepatitis C virus antibody
* Severe hepatic insufficiency (Child-Pugh C)
* Clinically significant cardio-cerebrovascular diseases
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: Zanubrutinib, DRUG: Tacrolimus
Primary Membranous Nephropathy
BGB-3111, Zanubrutinib, BTKi
I'm interested
Robotic vs. Open NSM for Early Stage Breast Cancer (SP NSM)
clinicaltrials@northshore.org
FEMALE
21 years and over
NA
This study is NOT accepting healthy volunteers
NCT05720039
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Inclusion Criteria:
* Female age 21 or older
* BMI \< 30
* Candidate for an NSM procedure with immediate reconstruction
* Diagnosis of early stage brest cancer
* Breast ptosis ≤ Grade 2.
* Cup size ≤ C.
Exclusion Criteria:
* Previous breast surgery
* Diagnosis of metastatic breast cancer
* Prior radiation treatment to the chest
* Current smokers
* Contraindication for general anesthesia or surgery.
* Known bleeding or clotting disorder.
* Pregnant or suspected to be pregnant, or actively breastfeeding
DEVICE: Robotic NSM, PROCEDURE: Open NSM
Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease, Breast
robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy, breast, USA, robot, SP System, Single-port
I'm interested
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS)
clinicaltrials@northshore.org
ALL
6 years to 17 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05723198
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Inclusion Criteria:
* Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
* Have severe areata alopecia (AA) for at least 1 year
* Diagnosis for at least 1 year
* Current AA episode of at least 6 months' duration
* SALT score ≥50% at screening and baseline
* History of trial and failure with at least 1 available treatment (topical or other) for AA
* History of psychological counseling related to AA
* Current episode of severe AA of less than 8 years.
* Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.
Exclusion Criteria:
* Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
* Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
* Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
* Have uncontrolled arterial hypertension
* Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.
* Have a positive test for hepatitis B virus (HBV) infection
* Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]).
* Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
Prospective Randomized Controlled Trial of Obstructed Defecation Surgery (PROD)
Jungeun (Camilla) Lee, MS - JLee5@northshore.org
FEMALE
18 years to 80 years old
NA
This study is NOT accepting healthy volunteers
NCT05747027
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Inclusion Criteria:
• Female, between the age of 18 and 80
• OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):
• Do you feel you need to strain too hard to have a bowel movement?
• Do you feel you have not completely emptied your bowels at the end of a bowel movement?
• Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?
• Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
• Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
• Patient who is not pregnant and does not intend to become pregnant in the next 2 years
• Available for 24-months of follow-up
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Able to complete study assessments, per clinician judgment
• Able and willing to provide independent written informed consent
• Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries
Exclusion Criteria:
• Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
• History of previous surgery that included any type of surgery for rectal prolapse
• Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
• Previous adverse reaction to synthetic mesh
• Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
• History of two inpatient hospitalizations for medical comorbidities in the previous 12 months
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation (LIBREXIA-AF)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05757869
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Inclusion Criteria:
* Minimum age of 18 years
* Medically stable and appropriate for chronic antithrombotic treatment
* Atrial fibrillation eligible to receive anticoagulation
* Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure
Exclusion Criteria:
* Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
* Any condition other than AF that requires chronic anticoagulation
Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo
Steven Greenberg, MD - sgreenberg@northshore.org
All
21 years to 90 years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05801679
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Inclusion Criteria:
• Subject must be an elective or urgent cardiac surgical patient undergoing
cardiopulmonary bypass at NorthShore University HealthSystem.
• Male or female subject aged 21 to 90 years, at the time of consent.
• Subject who can consent in English.
• Subjects who are eligible for fast track extubation as defined by those patients who
plan on being extubated within 24 hours of the end of surgery and optimally within the
6-hour STS benchmark time from end of surgery.
Exclusion Criteria:
• Subjects having emergency cardiac surgery.
• Subjects who cannot consent in English.
• Subjects who are not eligible to be extubated within 24 hours of the end of surgery.
• Subjects with neuromuscular disorders.
• Subjects on home oxygen.
• Subjects who have known allergies or reactions to rocuronium or sugammadex.
• Subjects with anticipated need for prolonged intubation by the clinical treating team.
• Subjects with a history of opioid abuse.
• Subjects on mechanical circulatory support.
• Subjects who have end stage renal disease requiring dialysis.
Drug: Sugammadex, Other: Placebo
Surgery
Anesthesia, Sugammadex, Cardiac Surgical Patients
I'm interested
Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
clinicaltrials@northshore.org
Male
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05806515
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Inclusion Criteria:
• Participant must have histologic diagnosis of prostate adenocarcinoma
• Participant must have high or very high-risk disease defined by at least one of the
following:
• cT3a - cT4x
• Grade group 4 or 5 (Gleason sum 8-10)
• PSA > 20 ng/mL prior to registration
• Participant must have documented evidence of germline mutation (pathogenic/likely
pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory
Improvement Act (CLIA)-certified lab
• NOTE: Local lab report is sufficient for eligibility
• Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH
antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other
agent intended to treat prostate cancer prior to registration. The effectiveness of
the current depot of such treatment must not extend beyond 1 month after study
registration. Agents listed above cannot be started after participant registration
• Participant must be >= 18 years old
• Participant must have Zubrod performance status of 0-2
• Participant must have a complete medical history and physical exam within 28 days
prior to registration
• Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to registration)
• Platelets >= 100 x 10^3/uL (within 28 days prior to registration)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional
upper limit of normal (ULN) (within 28 days prior to registration)
• Participant must have a serum creatinine =< the institutional upper limit of normal
(IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the following
Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28
days prior to registration
• Participant must have adequate cardiac function. Participants with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic agents,
must have a clinical risk assessment of cardiac function using the New York Heart
Association Functional Classification within 28 days prior to registration. To be
eligible for this trial, participants must be class 2B or better
• Participant with known human immunodeficiency virus (HIV)-infection must be receiving
anti-retroviral therapy and have an undetectable viral load test within 6 months prior
to registration
• Participant with history of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load on suppressive therapy within in 28 days prior to
registration
• Participant with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For participants with HCV infection who are currently on treatment must
have an undetectable HCV viral load within in 28 days prior to registration
• Participants who are of reproductive potential must have agreed to use an effective
contraceptive method with details provided as a part of the consent process. A person
who has semen likely to contain sperm is considered to be of "reproductive potential."
In addition to routine contraceptive methods, "effective contraception" also includes
refraining from sexual activity that might result in pregnancy and surgery intended to
prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy
with testing showing no sperm in the semen
• Prior to registration, participant must have had a urologic consult and be deemed a
surgical candidate with known sites of disease deemed by the urologist to be
potentially resectable
• Participants must be offered the opportunity to participate in specimen banking. With
participant consent, specimens must be collected and submitted via the Southwest
Oncology Group (SWOG) Specimen Tracking System
• NOTE: As a part of the OPEN registration process the treating institution's identity
is provided in order to ensure that the current (within 365 days) date of
institutional review board approval for this study has been entered in the system
• Participants must be informed of the investigational nature of this study and
must sign and give informed consent in accordance with institutional and federal
guidelines
• For participants with impaired decision-making capabilities, legally authorized
representatives may sign and give informed consent on behalf of study
participants in accordance with applicable federal, local, and Central
Institutional Review Board (CIRB) regulations
• As part of the registration process the treating institution's identity is
provided in order to ensure that the current (within 365 days) date of
institutional review board approval for this study has been entered in the system
Exclusion Criteria:
• Participant must not have evidence of distant metastatic disease by conventional
imaging within 90 days prior to registration
• NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites of
disease to be potentially completely resectable
• Participant must not have received prior radiation therapy (RT) to the pelvic region
• Participant must not have a prior or concurrent malignancy whose natural history or
treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of protocol treatment
Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
I'm interested
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)
clinicaltrials@northshore.org
ALL
22 years to 85 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05836987
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Inclusion Criteria:
• 22-85 years of age.
• English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.
• History of non-permanent atrial fibrillation.
• CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \< 40%.
• The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.
• Willing and able to comply with the protocol, including:
* Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan
* Be willing to wear the smart watch for the suggested minimum of 14 hours a day
* Expected to be within cellular service range at least 80% of the time
• Willing and able to discontinue DOAC
• The participant is willing and able to provide informed consent.
Exclusion Criteria:
• Valvular or permanent atrial fibrillation.
• Current treatment with warfarin and unwilling or unable to take a DOAC.
• The participant is a woman who is pregnant or nursing.
• The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
• Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment.
• Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.
• Any documented single AF episode lasting ≥ 1 hour on standard of care or study-provided external cardiac monitor of \> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI.
• Ablation for AF within the last 2 months.
• Prior or anticipated left atrial appendage occlusion or ligation.
• Mechanical prosthetic valve(s) or severe valve disease.
• Hypertrophic cardiomyopathy.
• Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).
• Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \> 75%) based on the investigator's discretion.
• The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.
• The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.
• The participant has a tremor on their ipsilateral side that the AFSW may be worn.
• Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
• Known hypersensitivity or contraindication to direct oral anticoagulants.
• Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
• Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
• \> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.
• History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).
• Stage 4 or 5 chronic kidney disease.
• Conditions associated with an increased risk of bleeding:
* Major surgery in the previous month
* Planned surgery or intervention in the next three months that would require cessation of anticoagulation \> 2 weeks.
* History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding
* Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)
* Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
* Hemorrhagic disorder or bleeding diathesis
* Need for anticoagulant treatment for disorders other than AF
* Uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg)
Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial
Henry Chill, MD - HChill@northshore.org
Female
45 years to 100 years old
N/A
This study is also accepting healthy volunteers
NCT05842005
Show full eligibility criteria
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Inclusion Criteria:
• Symptomatic stress urinary incontinence
Exclusion Criteria:
• Women of childbearing age (0-45 years)
• Previous stress urinary incontinence surgery
Device: Mesh-reduced Sling
Stress Urinary Incontinence
Mesh-reduced sling, Safety, Efficacy, Treatment
I'm interested
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE)
clinicaltrials@northshore.org
ALL
18 years to 63 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05843643
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Inclusion Criteria:
* Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
* At Screening, must have at least one of the following:
* antinuclear antibody (ANA) positive (titer \>= 1:80)
* anti-double stranded deoxyribonucleic acid (dsDNA) positive
* anti-Smith positive
* Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) \>= 6, of which \>= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as \>= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
* Physician's Global Assessment (PhGA) \>= 1 during screening period.
* On stable background treatment for \>= 60 days prior to Baseline (with the exception of oral corticosteroid \[OCS\], which must be at a stable dose for \>=14 days prior to Baseline) with
* antimalarial(s) \[hydroxychloroquine \<= 400 mg daily, chloroquine \<= 500 mg daily, quinacrine \<= 100 mg daily\];
* and/or prednisone (or prednisone-equivalent) (\<= 20 mg daily);
* and/or no more than 1 of the following: azathioprine (\<= 150 mg daily), 6-mercaptopurine (\<= 150 mg daily), mycophenolate mofetil (\<= 2 g daily), mycophenolate sodium \<= 1,440 mg/day, leflunomide (\<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (\<= 23.7 mg twice daily), methotrexate (\<= 25 mg weekly), or mizoribine (\<= 150 mg daily).
Exclusion Criteria:
* Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
* Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
* Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
* Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
* History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
* Pregnancy, breastfeeding, or considering becoming pregnant during the study.
* Clinically relevant or significant ECG abnormalities at Screening.
* Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of BION-1301 in Adults With IgA Nephropathy
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05852938
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Inclusion Criteria:
* Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Medical Monitor.
* eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation.
* Total urine protein ≥ 1.0 g/day and UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
* Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to Screening unless intolerant to ACEi/ARB. May also be on a stable and well tolerated dose of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the treatment of IgAN. Participants are expected to stay on the ACEi/ARB, SGLT2i and/or the ERAs/MRAs for the duration of the study.
* Body mass index (BMI) between 18 and 40 kg/m\^2.
* Screening weight of 45 to 150 kg.
* Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group \[CTFG\] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated \> 1 month prior to first dose of study drug.
* Provide written informed consent and be willing to comply with study visits and procedures.
Exclusion Criteria:
* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
* Diagnosis of IgA Vasculitis.
* Current or history of nephrotic syndrome.
* Average blood pressure \> 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator.
* Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines
* Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.
* History of Type 1 Diabetes.
* Participants with Type 2 diabetes are excluded if any of the following are present:
* Screening HbA1c (glycated hemoglobin) of \> 8%.
* Evidence of diabetic changes on kidney biopsy, performed for any reason.
* History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease).
* Unstable anti-diabetic regimen:
* Prior exposure to any antibody directed against APRIL.
* History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody.
* Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.
* Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening.
* Use of systemic immunosuppressant medications.
* Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants.
* Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.
* Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening.
* Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.
* History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A participant with curatively treated cervical carcinoma in situ is eligible for the study. Participants with low-risk prostate cancer (i.e., Gleason score \< 7 and prostate specific antigen \< 10 ng/mL) are allowed.
* Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
* History or evidence of any other clinically significant disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the participant at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results.
* IgG levels \< 6 g/L at Screening.
* Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
clinicaltrials@northshore.org
ALL
12 years to 100 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05882877
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Inclusion Criteria:
* Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
* Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
Exclusion Criteria:
* Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.
DRUG: Rocatinlimab, OTHER: Placebo
Atopic Dermatitis
Atopic Dermatitis, Rocatinlimab, AMG 451, Eczema
I'm interested
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS)
clinicaltrials@northshore.org
ALL
12 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05889182
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Inclusion Criteria:
* Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject).
* Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
* Participant must have a total AN count of ≥ 5 at Baseline.
* HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
* At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
* Draining fistula count of ≤ 20 at Baseline.
Exclusion Criteria:
* History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
* Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
* Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
* Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.
Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
Dacey Maglaque - dmaglaque2@northshore.org
MALE
50 years and over
This study is NOT accepting healthy volunteers
NCT05898932
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Inclusion Criteria:
• Male sex
• Age 50 years or older
• Diagnosed by physician with BPH
• Able and willing to complete questionnaires
• Able and willing to provide informed consent
• Ability to read, write, and speak in English
• No plans to move from study area in next 6 months
Exclusion Criteria:
• Female sex or intersex
• Younger than 50 years of age
• Being a prisoner or detainee
• Gross hematuria
• Interstitial cystitis
• Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)
• History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy
• Ongoing symptomatic urethral stricture
• Current chemotherapy or other cancer therapy
• History of lower urinary tract or pelvic malignancy
• Severe neurological of psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)
• Current moderate or severe substance use disorder
OTHER: Medical Management, OTHER: Surgical Management
Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
Johnny K Lee, MD - JLee8@northshore.org
All
18 years to 90 years old
Phase 4
This study is also accepting healthy volunteers
NCT05900427
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Inclusion Criteria:
• Subject ages 18-90 years old
• Male or Female subjects
• Weight ≥ 60 kg.
• Must be able to consent in English
Exclusion Criteria:
• Ages: <18 and >90
• Weight < 60 kg
• Multiple surgeries during one hospital stay
• Emergency surgery
• Allergy or any contraindication to local anesthetics used in trial.
• Pregnancy
• Contraindicated for use of liposomal bupivacaine
• Severe liver/kidney disease
• Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis
• Subject who received another local anesthetic block prior to the interscalene block.
• Unable to consent in English
Drug: Liposomal bupivacaine, Drug: Bupivacaine
Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
I'm interested
Splint Users' Satisfaction and Functional Status With Custom Finger Splints
Natasha Irani, OTD, BA - nirani@schosp.org
All
18 years and over
N/A
This study is NOT accepting healthy volunteers
NCT05903391
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Inclusion Criteria:
• Fluent in English
• 18 years or older
• Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without
swan-neck deformity)
• Pregnant or not pregnant women
• Able to tolerate a finger orthosis over the course of 1 month
• Not decisionally impaired
• Have or have not previously worn a finger orthosis for symptoms
Exclusion Criteria:
• Non-fluent in English
• Decisionally impaired
• Younger than 18 years old
• No proximal interphalangeal joint (PIP) joint finger hyperextension
• Unable to tolerate a finger orthosis over the course of 1 month
Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia
Steven Greenberg, MD - sgreenberg@northshore.org
All
18 years to 90 years old
N/A
This study is also accepting healthy volunteers
NCT05953428
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Inclusion Criteria:
• Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
• Elective Laparoscopic hiatal hernia repair
Exclusion Criteria:
• Patients receiving urgent or emergent hiatal hernia surgery
• Patients receiving hiatal hernia surgery without laparoscopy
• Patients with adverse reactions (e.g., anaphylaxis, rash) to any of the drugs in the
OBA or OSA protocols.
Opioid Sparing Anesthesia Protocol, Opioid Based Anesthesia Protocol
I'm interested
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
clinicaltrials@northshore.org
All
18 years and over
This study is NOT accepting healthy volunteers
NCT05974150
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Inclusion Criteria:
• All participants must be 18 years of age or older.
• Subjects may be any stage and anywhere in the treatment continuum.
• Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or
multiple myeloma.
• Subjects must be able to complete on-line surveys using a cell phone, tablet, or
computer.
• All participants must be able to understand English.
Exclusion Criteria:
• Any patient who cannot understand written or spoken English.
• Any patient without the ability to complete on-line surveys using a cell phone,
tablet, or computer.
• Any patient on a treatment clinical trial.
• Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B,
C and D).
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
clinicaltrials@northshore.org
ALL
18 years to 100 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05976243
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Inclusion Criteria for core period:
• Male and female participants ≥18 years of age at the time of signing of the ICFs
• Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization
• The following response to the provocation test for each subtype is required at the randomization visit :
* Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
* Cold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
* Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test.
• Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.
• Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
Inclusion criteria for the OLE:
• Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period
Exclusion Criteria for core period:
* 1. Previous use of remibrutinib or other BTK inhibitors.
• Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study.
• Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
• Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study.
• Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema
• Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
There are no exclusion criteria for OLE
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