Search Results
225results
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT06703073
Inclusion Criteria:
* Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements
* Participant is at least 18 years of age or older at the time of consent.
* Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS.
Note that participants on noninvasive ventilation may be screened.
* Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply
* Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90).
Exclusion Criteria:
* Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.
* Participant with pulmonary edema due to cardiogenic pulmonary edema/fluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.
* Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions.
* Participant is known to be pregnant, nursing, or with a positive (urine and/or serum test) pregnancy test.
* Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.
* Participant is not expected to survive for 72 hours.
* Participant has been on invasive mechanical ventilation or ECMO for more than 48 hours for ARDS at the time of consent.
* Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation
* Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing.
* Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.
* Participant has NY Heart Association Class IV congestive heart failure.
* Participant has a known allergy to any study medication or any of its excipients.
* Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication.
NOTE: Patients on chronic low dose immunosuppressive therapy may be enrolled at the discretion of the investigator in consultation with the medical monitor.
* Participant is undergoing active cancer systemic chemotherapy.
* Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.
* Participant with concurrent infections or history of the following:
• Known active tuberculosis,
• Known active Hepatitis B, or
• HIV and a CD4 count less than 50 or a detectable viral load of \>200 copies/mL HIV RNA. * Participant received treatment with any other investigational drugs within 30 days prior to consent. * Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening. * Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. Participant may have additional cohort-specific requirements.
DRUG: Cohort A: vilobelimab, DRUG: Cohort A: placebo, DRUG: Cohort B: paridiprubart, DRUG: Cohort B: placebo, DRUG: Cohort C: bevacizumab, DRUG: Cohort C: placebo
Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome
BARDA, JUST BREATHE, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata (B7981027)
clinicaltrials@northshore.org
ALL
6 years to 11 years old
PHASE3
NCT07029711
Inclusion Criteria:
* A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU)) with at least 50% scalp hair loss due to AA (ie, SALT score of ≥50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.
* For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)
* Documented evidence of having received varicella vaccination (2 doses), OR evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.
Exclusion Criteria:
* Other (non-AA) types of alopecia, including any known congenital cause of AA.
* Pre-existing hearing loss.
* Any present or history of malignancies or lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
* Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score ≥70).
* Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention. DRUG: Ritlecitinib higher dose, DRUG: Ritlecitinib lower dose, DRUG: Placebo
Severe Alopecia Areata
Alopecia areata, Children, Ritlecitinib
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss (AMAZE 12)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07503210
Inclusion Criteria:
* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
Exclusion Criteria:
* Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% \[48 millimoles per mole (mmol/mol)\] as measured by the central laboratory at screening.
* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP 1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening. DRUG: NNC0487-0111, DRUG: Placebo (matched to NNC0487-0111)
Obesity
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07062965
Inclusion Criteria:
* Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
* Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.
* Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
Exclusion Criteria:
* Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
* Received greater than two prior lines of systemic therapy in the advance or metastatic setting
* Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.
* Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
* Renal impairment, hepatic dysfunction, or hematologic abnormalities. DRUG: PF-07248144, DRUG: Fulvestrant, DRUG: Everolimus, DRUG: Exemestane
Breast Cancer
Locally advanced or metastatic breast cancer, Estrogen receptor positive [ER(+)], Progesterone receptor positive [PR(+)], Human epidermal growth factor receptor 2 negative [HER2(-)], ER(+)/HER2(-), PR(+)/HER2(-), HR(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Breast cancer, Everolimus, Exemestane, Fulvestrant, Metastatic breast cancer, Endocrine Therapy, Hormone Therapy, Hormone positive breast cancer, Recurrent breast cancer, HR+, HER2-negative, Relapse, Recurrent, Second line treatment, Third line treatment, Left Sided Breast Cancer, Right Sided Breast Cancer, Unilateral Breast Cancer, Cancer of the Breast, CDK4/6i, CDK4/6i-based Therapy, Bilateral Breast Cancer, Progression After CDK4/6i-based therapy
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
clinicaltrials@northshore.org
ALL
4 years and over
PHASE4
NCT06834165
Inclusion Criteria:
* Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.
* Has body weight 15 kg or greater at the time of allergy challenge.
* Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself.
* Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.
Exclusion Criteria:
\- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator. DRUG: Neffy, DRUG: Adrenaline
Allergic Reactions
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH)
clinicaltrials@northshore.org
MALE
18 years and over
PHASE3
NCT06592924
Inclusion Criteria:
* Histologically/cytologically confirmed adenocarcinoma of the prostate
* Metastatic disease by conventional imaging
* PSA of ≥5.0 ng/ml (5.0 ug/L) prior to commencement of ADT
* Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months at time of enrollment.
* Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months at time of enrollment
* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
* Serum testosterone \<1.7 nmol/L or 50 ng/dL.
* PSA ≥ 0.2 ng/ml (0.2 ug/L) within 14 days of enrollment. If there is any rise in PSA since starting ADT and achieving castrate-level testosterone, PSA must be repeated and must not fulfill ineligibility criteria 4.2.1.
* Candidate for docetaxel chemotherapy
* ECOG Performance Status (PS) 0 to 2.
* Adequate organ and marrow function measured within 14 days prior to enrollment.
* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* In accordance with CCTG policy, protocol treatment is to begin within 5 working days of participant enrollment.
* If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception
* HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Participant access to all protocol therapies must be confirmed prior to enrollment
Exclusion Criteria:
* Two consecutive rises in PSA since achieving castration on ADT at least 2 weeks apart with at least one PSA ≥5% above the PSA nadir and with at least one PSA having an absolute increase of ≥0.5 ng/ml above the PSA nadir.
* Evidence of radiographic progression or clinical progression since start of ADT.
* Docetaxel criteria:
* Prior treatment with taxane chemotherapy
* Grade 2 or worse peripheral neuropathy
* Severe hypersensitivity to drugs formulated with polysorbate 80
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.
* Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.
* Live attenuated vaccination administered within 30 days prior to enrollment/randomization.
* For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Participants 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, they are eligible if they have an undetectable HCV viral load.
* High-grade neuroendocrine prostate cancer or small cell features. DRUG: Abiraterone, DRUG: Enzalutamide, DRUG: Apalutamide, DRUG: Darolutamide (BAY 1841788), DRUG: Docetaxel, DRUG: ADT
Prostate Cancer (Adenocarcinoma)
PR26, Castration sensitive
The PREDICT Registry:
clinicaltrials@northshore.org
FEMALE
30 years to 85 years old
NCT03448926
Inclusion criteria
• Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
• Patient must have the DCISionRT test ordered during routine patient care.
• Patient must be eligible for or have recently completed breast conserving surgery.
• Patient must be eligible to receive radiation and/or systemic treatment.
• Patient must be 30 to 85 years old.
• Patient must have tumor size of less than 6 cm.
• Patient must have been diagnosed with DCIS within 120 days of consent. Exclusion criteria
• Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
• Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
• Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
• Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
• Patient has a prior history of in-field radiation in the ipsilateral breast.
• Patient has had prior systemic endocrine or chemotherapy prior to testing.
• Patient is pregnant.
• Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
• Patient must have the DCISionRT test ordered during routine patient care.
• Patient must be eligible for or have recently completed breast conserving surgery.
• Patient must be eligible to receive radiation and/or systemic treatment.
• Patient must be 30 to 85 years old.
• Patient must have tumor size of less than 6 cm.
• Patient must have been diagnosed with DCIS within 120 days of consent. Exclusion criteria
• Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
• Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
• Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
• Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
• Patient has a prior history of in-field radiation in the ipsilateral breast.
• Patient has had prior systemic endocrine or chemotherapy prior to testing.
• Patient is pregnant.
OTHER: Treatment recommendation surveys, DEVICE: 7-gene biosignature
DCIS, Stage 0 Breast Cancer, Ductal Breast Carcinoma In Situ
DCIS, molecular testing, risk of recurrence, treatment decision, decision impact, predictive
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)
clinicaltrials@northshore.org
ALL
45 years to 99 years old
PHASE3
NCT07037433
Inclusion Criteria
* Age ≥ 45 years at screening.
* BMI of ≥ 27.0 kg/m\^2 at screening.
* History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:
* Prior MI (presumed atherothrombotic event due to plaque rupture/erosion).
* Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).
* Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \< 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.
Exclusion Criteria
* History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).
* New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.
* Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.
* For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):
* HbA1c \> 10.0% (86 mmol/mol) at screening.
* History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization.
* One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness.
* History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema.
* Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial.
* History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization.
* Family (first-degree relative\[s\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* Calcitonin ≥ 50 ng/L (pg/mL) at screening.
* Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).
* History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).
* Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.
DRUG: Maridebart Cafraglutide, DRUG: Placebo
Atherosclerotic Cardiovascular Disease, Overweight, Obesity
Atherosclerotic Cardiovascular Disease, Overweight, Obesity, Maridebart cafraglutide, AMG 133, MariTide
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants (ROXI-ASPEN)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07213778
Key
• Is undergoing a primary elective unilateral TKA
• Is in good health based on laboratory safety testing as described in the protocol Key
• Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation
• History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency)
• History of thromboembolic disease or thrombophilia
• History of platelet dysfunction
• Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Inclusion Criteria:
• Is undergoing a primary elective unilateral TKA
• Is in good health based on laboratory safety testing as described in the protocol Key
Exclusion Criteria:
• Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation
• History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency)
• History of thromboembolic disease or thrombophilia
• History of platelet dysfunction
• Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply
DRUG: REGN7508, DRUG: Acetylsalicylic Acid (ASA), DRUG: Placebo
Symptomatic Venous Thromboembolism (VTE)
Total Knee Arthroplasty (TKA), Elective Unilateral TKA, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.
clinicaltrials@northshore.org
ALL
18 years to 75 years old
PHASE2
NCT07228390
Key Eligibility Criteria:
• Male or female participants ≥18 to ≤75 years of age.
• Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS.
• Presence of ≥20 draining fistulae at Screening or BL visit
• Evidence of other active skin disease or condition at screening
• Have a known immunodeficiency disorder
• Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years
Inclusion Criteria:
• Male or female participants ≥18 to ≤75 years of age.
• Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS.
Exclusion Criteria:
• Presence of ≥20 draining fistulae at Screening or BL visit
• Evidence of other active skin disease or condition at screening
• Have a known immunodeficiency disorder
• Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years
DRUG: Ritlecitinib, DRUG: Placebo
Hidradenitis Suppurativa
Ritlecitinib
Patient Quality of Recovery After TAVR With Different Sedation Regimens
clinicaltrials@northshore.org
ALL
18 years to 90 years old
PHASE4
NCT07556523
Inclusion Criteria:
* 18-90 years old, inclusive
* Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)
* Speaks English or Spanish
* Consents to participate
Exclusion Criteria:
* Preoperative heart rate \< 50 bpm or arrhythmias (e.g., AFib with RVR)
* Conduction abnormalities (e.g., 2nd/3rd degree AV block without pacer)
* Allergy or contraindication to study drugs
* Pulmonary artery pressure \> 70mmHg
* Morbid obesity BMI \> 50
* Pregnancy
* Unable to consent in English or Spanish DRUG: Propofol, DRUG: Dexmedetomidine, DRUG: Midazolam, DRUG: Fentanyl
Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
Transcatheter aortic valve replacement, TAVR, Sedation strategy, Anesthesia
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07256392
Key
• Written informed consent
• Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).
• Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment.
• Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary. Key
• Active pruritic skin condition in addition to CSU.
• Medical condition that would cause additional risk or interfere with study procedures.
• Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Inclusion Criteria:
• Written informed consent
• Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).
• Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment.
• Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary. Key
Exclusion Criteria:
• Active pruritic skin condition in addition to CSU.
• Medical condition that would cause additional risk or interfere with study procedures.
• Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
BIOLOGICAL: barzolvolimab, OTHER: Standard of Care
Chronic Spontaneous Urticaria
CDX-0159, barzolvolimab, chronic spontaneous urticaria, CSU, urticaria activity score, itch severity score
Vivistim Registry for Paired VNS Therapy (GRASP) (GRASP)
clinicaltrials@northshore.org
ALL
22 years and over
NCT05301140
Inclusion Criteria:
* Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke
Exclusion Criteria:
* Not eligible for surgery DEVICE: Vivistim System
Upper Extremity Problem
Ischemic Stroke, Paired Vagus Nerve Stimulation
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair
clinicaltrials@northshore.org
ALL
18 years to 80 years old
PHASE2
NCT07226791
Inclusion Criteria:
\- Midline ventral hernia requiring open surgical repair.
Exclusion Criteria:
* Medical condition that may put the participant at increased risk with exposure to AGN-151607-DP, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function.
* History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening. DRUG: AGN-151607-DP, DRUG: Placebo for AGN-151607-DP
Ventral Hernia
Ventral Hernia, AGN-151607-DP, Primary fascial closure, Open Abdominal Ventral Hernia Repair
A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis
clinicaltrials@northshore.org
ALL
18 years to 65 years old
PHASE2
NCT07599813
Inclusion Criteria:
• Age 18-65 inclusive, at the time of signing the informed consent.
• Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
• Participants with moderate-to-severe AD defined by:
• Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Screening and Baseline.
• AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.
• EASI score of ≥ 16 at Screening and at Baseline.
• Peak pruritus numerical rating scale (PP-NRS) ≥ 4 at Baseline. Note: The PP-NRS will be calculated from the 7 consecutive days immediately preceding Baseline. A minimum of 4 daily scores out of the 7 days is needed.
• Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participant provides signed informed consent
Exclusion Criteria:
• History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
• Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
• Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments based on the Investigator's judgement.
• Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
• Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.
• Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.
• Participant has severe and uncontrolled seasonal or allergic rhinitis, severe and uncontrolled asthma or any other severe and uncontrolled atopic disease as judged by the Investigator.
• Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.
• Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.
• Active hepatitis B virus (HBV): hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+) confirmed by HBV PCR positive (+).
• Active hepatitis C virus (HCV): If hepatitis C antibody positive (+), confirmed by HCV RNA test. Note: a participant with documented proof of cure from HCV may be enrolled.
• Evidence of active or latent tuberculosis.
• Receipt of live or attenuated live vaccine within 6 weeks prior to screening.
• Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
• Participant is known to have immune deficiency or is immunocompromised
• Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of: * Completely resected basal cell or squamous cell carcinoma of the skin. * Carcinoma in situ of the cervix.
• Has had previous exposure to anti-IL-18 therapy.
• Known allergy/sensitivity to any component of IMP.
• History of use of any of these medications as follows:
• Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline.
• Systemic JAKi within 4 weeks prior to Baseline.
• Any topical medicated treatment that could affect AD within 2 weeks prior to Baseline, including, but not limited to, topical corticosteroids, topical phosphodiesterase (PDE4) inhibitors, topical calcineurin inhibitors, topical JAKi, tars, antimicrobials, medical devices, and bleach baths.
• Systemic therapies (other than biologics) that could affect AD not noted above, within 4 weeks prior to Baseline, including but not limited to, retinoids, calcineurin inhibitors, methotrexate, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
• Treatment with any investigational biologic agent or biologic agent approved after publication of this protocol, within 12 weeks (or 5 half-lives, whichever is greater) of screening.
• Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening.
• UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study.
• PUVA treatment within 4 weeks prior to Baseline
• Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline
• Topical products containing urea within 1 week prior to Baseline
• Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline
• Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline.
• Female participant who is pregnant or breastfeeding or trying to conceive.
• Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator.
DRUG: Camoteskimab, DRUG: Placebo
Atopic Dermatitis, Atopic, Dermatitis, Dermatitis, Atopic, Dermatologic Disease, Eczema, Eczema Atopic Dermatitis, Eczema, Atopic