Search Results
229results
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer (AMPLIFY)
clinicaltrials@northshore.org
MALE
18 years and over
PHASE3
NCT06970847
Inclusion Criteria:
• At least 18 years of age.
• Signed informed consent.
• Life expectancy ≥ 6 months as determined by the Investigator.
• Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
• Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
• PSA level after definitive therapy:
• Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
• Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
• Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
• An Eastern Cooperative Oncology performance status of 0-2.
Exclusion Criteria:
• Participants who received investigational agent within 5 biological half-lives prior to Day 1.
• Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
• Participants with known predominant small cell or neuroendocrine PC.
• Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation).
• Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
• Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant's involvement in the study.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
• Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.
DRUG: 64Cu-SAR-bisPSMA
Prostate Cancer, Prostate Cancer Patients With Detectable PSA Following Prostatectomy, Prostate Cancer Recurrent, Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Cryotherapy
Prostate Cancer, Prostate, Biochemical Recurrence
Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI) (CLEAR-AKI)
clinicaltrials@northshore.org
ALL
18 years to 85 years old
PHASE2
NCT05996835
Inclusion Criteria:
• Signed informed consent must be obtained in accordance with local regulations.
• ≥ 18 to ≤ 85 years of age
• Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
• Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: * Suspected or confirmed infection AND * Acute increase of SOFA score of 2 or more (excluding renal component). The baseline SOFA score should be assumed to be zero unless the participant is known to have pre-existing (acute or chronic) organ dysfunction before the onset of infection
• Diagnosis of AKI Stage 1 or greater per the following criterion at randomization: An absolute increase in serum or plasma creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference serum creatinine. * For participants with hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI diagnosis should be used as the reference serum creatinine. * For participants presenting from community, the reference serum creatinine should be estimated using the following order of preference:
• The most recent value within 3 months of the hospital admission. If not available:
• The most recent value between 3 and 12 months prior to hospital admission. If not available:
• At hospital admission Exclusion criteria
• Not expected to survive for 24 hours
• Not expected to survive for 30 days due to medical conditions other than SA-AKI
• History of CKD with a documented estimated GFR \<30 mL/min prior to admission to hospital
• eGFR \<45mL/min at admission without any other reference serum eGFR within last 12-months
• Receiving RRT or a decision has been made to initiate RRT within 24 hours after randomization
• Weight is less than 40 kg or more than 125 kg.
• Limitations to the use of mechanical ventilation, RRT or vasopressors/inotropes (N.B. limitations on Cardiopulmonary resuscitation (CPR)e.g., do-not-resuscitate orders are not an exclusion criterion unless associated with likely poor outcome in next 24 hours)
• Sepsis diagnosis according to sepsis inclusion criteria for a period longer than 72 hours prior to ICU admission
• AKI diagnosis according to AKI inclusion criteria over 48 hours after admission to ICU
• Inability to administer study drug within 24 hours of diagnosis of AKI according to AKI inclusion criteria
• Presence of AKI, in the Investigator's opinion, as suggested by clinical manifestation, e.g., prolonged oliguria or severe renal dysfunction on admission without a history of CKD, for a period longer than 24 hours prior to study drug administration
• Evidence of recovery from AKI based on the investigator's clinical judgement prior to randomization
• AKI is most likely attributable to other causes than sepsis, such as nephrotoxic drugs (Non-steroidal anti-inflammatory drugs (NSAIDs), contrast, aminoglycosides, etc.) or renal perfusion-related (acute abdominal aortic aneurysm, dissection, renal artery stenosis), urinary obstruction
• Documented (biopsy proven) or suspected history of acute or sub-acute kidney diseases such as rapidly progressive glomerular nephritis (RPGN) and acute interstitial nephritis (AIN)
• Patients who are post-nephrectomy
• Patients with permanent incapacitation
• Patients who are thrombocytopenic at screening (platelet count \<50,000 per microliter) who have active/uncontrolled bleeding or who present current or past conditions indicating high risk for bleeding in the opinion of the investigator (e.g. coagulopathies, previous history of major non-traumatic bleeding etc.)
• Immunosuppressed patients * History of immunodeficiency diseases * Receiving immunosuppressant treatment or on chronic high doses (high-dose therapy exceeding 2 weeks of treatment) of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with corticosteroids (as per the Surviving Sepsis Guidelines) can be included.
• Patients with known or presumed latent or active TB based on clinical history or imaging e.g. patients on TB preventive therapy or close/household contacts of pulmonary TB patients
• Known active hepatitis B or C infection (clinical diagnosis or positive infection serology), or advanced chronic liver disease, confirmed by a Child-Pugh score of 10-15 (Class C)
• Acute pancreatitis with no established source of infection
• Active hematological malignancy (previous hematological malignancies that are not actively treated are allowable)
• Burns requiring ICU treatment
• Sepsis attributed to confirmed COVID-19
• Use of other investigational drugs within 5 half-lives of enrollment, within 30 days (e.g., small molecules) or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations
• History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes
• Any medical conditions that could significantly increase risk of participants' safety by participating in this study according to investigator's judgement
• Women with a positive pregnancy test, pregnancy or breast feeding
• Women of childbearing potential, unless they are using highly effective methods of contraception for the entire duration of the trial.
BIOLOGICAL: TIN816 70 mg lyophilisate powder, OTHER: Placebo
Acute Kidney Injury Due to Sepsis
Sepsis, acute kidney injury, anti-inflammatory, immunosuppression, intensive care unit
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis (Adoring)
clinicaltrials@northshore.org
ALL
3 months to 23 months old
PHASE3
NCT07265479
Inclusion Criteria:
* Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \<24 months of age at the Screening visit.
* Clinical diagnosis of atopic dermatitis (AD), AD covering \>5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4
* Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities
* Legal guardian or primary caregiver is able and willing to adhere to protocol requirements
Exclusion Criteria:
* Significant neurological disorder or history of seizure
* Know clinically significant cardiac rhythm or cardiac disorder
* History of sudden infant death in a sibling
* Clinically significant chromosome abnormality
* History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation
* Diseases that could cause pruritic and/or sleep disruption
* Immunocompromised
* Current chronic or acute infection requiring treatment
* Use of prohibited medication(s) or procedure(s)
* Use of prohibited medications by breastfeeding mother if breastfeeding participant DRUG: Tapinarof cream, 1%, DRUG: Vehicle Cream
Atopic Dermatitis
Pediatric Atopic Dermatitis, Eczema, tapinarof, topical
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight (AMAZE 1)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07339423
Key
Inclusion Criteria:
* Male or female (sex at birth).
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.
Key Exclusion Criteria:
* HbA1c ≥ 6.5% (48 millimole 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
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)
clinicaltrials@northshore.org
FEMALE
18 years and over
PHASE3
NCT07214779
Inclusion Criteria:
* Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* Have platinum-resistant disease.
* Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.
* Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
* Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
* Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
* Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
* Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
* Measurable disease per RECIST v1.1.
Exclusion Criteria:
* Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
* Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
* Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
* Clinically significant gastrointestinal abnormalities.
Other protocol-defined Inclusion/Exclusion Criteria may apply. DRUG: INCB123667, DRUG: Investigator's choice of chemotherapy
Ovarian Cancer
INCB123667
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
clinicaltrials@northshore.org
ALL
18 years and over
NCT06218875
Inclusion Criteria:
• Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
• Patient has been or is intended to be treated with an eligible registry device
• Patient is age ≥ 18 years at time of informed consent signature.
Exclusion Criteria:
• Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
• Patient with exclusion criteria required by local law.
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
AAA - Abdominal Aortic Aneurysm
Aneurysm, Aneurysm Repair, Endovascular, EVAR, Endoprosthesis, Aortic, Aortic Repair
A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07284849
Inclusion Criteria:
* Stage IV colorectal adenocarcinoma not amenable to curative resection.
* No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.
* Measurable disease per RECIST v1.1.
* ECOG performance status of 0 or 1.
* Adequate organ function determined by laboratory results.
Exclusion Criteria:
* MSI-H/dMMR per historical data in the medical record.
* BRAF V600E mutation per historical data in the medical record.
* Untreated and/or progressing CNS metastases.
* History of other malignancy within 2 years.
* Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* Significant concurrent and/or uncontrolled medical condition.
* History of organ transplant, including allogeneic stem cell transplantation.
Other protocol-defined inclusion/exclusion criteria apply. DRUG: INCA33890, DRUG: Placebo, DRUG: Bevacizumab, DRUG: FOLFOX
CRC (Colorectal Cancer)
Metastatic Colorectal Cancer, Colon Cancer, INCA33890
Zinc Supplementation With Botulinum Toxin for Overactive Bladder
clinicaltrials@northshore.org
FEMALE
21 years to 100 years old
PHASE2
NCT07405554
Inclusion Criteria:
* Non-pregnant adult female at least 21 years old, with no plans to become pregnant during the course of the trial) and if of child-bearing potential, with a negative pregnancy test, and if sexually active, must be using medically acceptable contraception.
* ≥ 6 urgency urinary incontinence episodes on a 3-day baseline bladder diary, with these urge incontinence episodes representing greater than 50% of the total incontinent episodes recorded.
* Willing and able to complete all study related items and interviews.
* Refractory urgency urinary incontinence: defined as persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, supervised physical therapy)
* Persistent symptoms despite the use of a minimum of two anticholinergics, or unable to tolerate medication due to side effects, or has a contraindication to taking anticholinergic/Beta 3 agonist medication.
* Currently not on an anticholinergic or antimuscarinic/Beta 3 agonist medication (e.g. oxybutynin, tolterodine, darifenacin, trospium chloride, solifenacin-succinate, fesoterodine and/or mirabegron) or be willing to stop medication for 3 weeks prior to completing baseline bladder diary and expected to remain off medications through duration of study.
* Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.
* Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function.
Exclusion Criteria:
* Neurologic diseases such as multiple sclerosis, Parkinson Disease, CVA within 6 months prior to enrollment, myasthenia gravis, Charcot-Marie-Tooth disease, clinically significant peripheral neuropathy, and complete spinal cord injury.
* Untreated urinary tract infection (UTI).
* Any prior use of either study therapy for treatment of urinary urge incontinence (Botox A® or Interstim®).
* PVR \>150 ml on 2 occasions within 6 months prior to enrollment (If the PVR value was obtained by ultrasound and was ≥150 ml, the PVR will be confirmed by catheterization which will be the gold standard).
* Current or prior bladder malignancy.
* Surgically altered detrusor muscle, such as augmentation cystoplasty.
* Subjects taking aminoglycosides.
* Currently pregnant or lactating.
* Allergy to lidocaine or bupivacaine.
* Prior pelvic radiation.
* Uninvestigated hematuria. DRUG: Zinc Citrate Oral Capsule, DRUG: Placebo
Overactive Bladder (OAB)
overactive bladder, botulinum toxin, zinc
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT07061964
Inclusion Criteria:
* Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)
* Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0
* Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed
* NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT
* Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT
* Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement
* NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)
* Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT
* Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology
* Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy
* NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (\> 50%) of the tumor is urothelial cell carcinoma
* Participants will be allowed to continue PD-1/L-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)
* Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine \[GC\] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor
* Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC
* NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed
* Participants must not have had prior pelvic radiotherapy
* Participants must not have received a live attenuated vaccination within 28 days prior to registration
* Participants with conditions requiring immunosuppressive doses of steroids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration
* Participants must be ≥ 18 years old at the time of registration
* Participants must have Zubrod performance status of 0-2
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)
* Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)
* Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
* Participants 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
* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* For participants with evidence 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 (defined as undetectable HCV viral load)
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must be offered the opportunity to participate in specimen banking
* Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Cystoscopy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Pembrolizumab, RADIATION: Photon Beam Radiation Therapy, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, PROCEDURE: Transurethral Resection of Bladder Tumor
Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
clinicaltrials@northshore.org
ALL
18 years and over
NA
NCT06959524
Clinical
Inclusion Criteria:
* Subject must be at least 18 years of age.
* Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.
* Subject is eligible for percutaneous coronary intervention (PCI).
* Subject is willing to comply with all protocol-required follow-up evaluation.
* Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
Angiographic Inclusion Criteria:
* Target lesion is a de novo lesion located in a native coronary artery
* Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic subjects (\>70% and \<100% in asymptomatic subjects) prior to lesion pre-dilation.
* Target lesion must be successfully pre-dilated.
* If a non-target lesion is treated, it must be treated first and must be deemed a success.
Clinical Exclusion Criteria:
* Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months.
* Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
* Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
* Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.
* Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
* Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.
* Subject has left ventricular ejection fraction known to be \< 30%.
* Subject had PCI or other coronary interventions within the last 30 days.
* Subject has planned PCI or CABG after the index procedure.
* Subject had STEMI or QWMI \<72h prior to the index procedure.
* Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable.
* Subject has cardiogenic shock (SBP \< 80 mmHg requiring inotropes, IABP or fluid support).
* Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
* Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion.
* Subject has known allergy to paclitaxel or other components of the used medical devices.
* Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.
* Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure.
* Subject has platelet count \< 100k/mm3 (risk of bleeding) or \> 700k/mm3.
* Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).
Angiographic Exclusion Criteria:
* In-stent restenosis.
* Target lesion is located within a saphenous vein or arterial graft.
* Target lesion is a total occlusion or has evidence of thrombus present in the target vessel.
* Target lesion is severely calcified by angiography or has \> 270° calcium arc on intravascular imaging or requires atherectomy.
* Subject has unprotected left main coronary artery disease (\>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels.
* Subject with planned treatment of lesion involving aortic ostial location. DEVICE: Drug Eluting Balloon, DEVICE: Drug eluting stent, PROCEDURE: Plain old balloon angioplasty
Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
Drug Coated Balloon, de novo, 97279374
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT06672146
Inclusion Criteria:
* Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have disease with a detectable IDH2 mutation based on central testing through the MYELOMATCH and be assigned to this clinical trial via MATCHBox prior to registration to this study
* Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
* Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by having ≥ 20% blasts in the bone marrow and/or peripheral blood, excluding acute promyelocytic leukemia (APL) with PML-RARA
* Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy
* Participants must not have received prior therapy for AML or myelodysplastic syndrome (MDS) and/or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), colony-stimulating factors, erythropoiesis-stimulating agents, immunosuppressive therapy, intrathecal chemotherapy, a single dose of cytarabine for cytoreduction, and/or leukapheresis
* Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide are allowed. Participants may receive hydroxyurea prior to treatment assignment on this substudy for cytoreduction but must agree to discontinue hydroxyurea prior to beginning treatment on this substudy
* White blood cell (WBC) must be \< 25 x 10\^9/L. Hydroxyurea, leukapheresis, and cytarabine \< 1 g/m\^2 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to initiation of protocol therapy
* Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy
* Participants must have Zubrod Performance Status of 0-3 as determined by a history and physical (H\&P) exam completed within 14 days prior to registration
* Participants must have a complete medical history and physical exam within 14 days prior to registration
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN (within 14 days prior to registration)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement (within 14 days prior to registration)
* Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration
* Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF).
* NOTE: Since older participants are at risk for prolonged QTc and may require supportive care with agents that affect QTc, an electrocardiogram (ECG) is recommended if clinically indicated. If the QTc is prolonged, they should be treated on MYELOMATCH TAP instead of MM1OA-S03
* Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
* Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted
* Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH). Participants enrolled in MYELOMATCH will submit bone marrow samples, peripheral blood samples, and buccal swabs to the Molecular Diagnostics Network (MDNet), the Clinical Laboratory Improvement Act (CLIA) laboratory network for myeloMATCH
* In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy. These specimens will be derived from procedures performed as part of standard assessments in the clinical care and management of AML with material being sent to the MDNet laboratories as specified. After performing the required tests on the specimens, the MDNet laboratories will send the residual material for biobanking and future research. Therefore, participants must be asked for their consent for the biobanking of specimens for future unspecified research. Participants may refuse this, but it is mandatory for sites to ask participants
* Participants must be offered the opportunity to participate in specimen banking
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Enasidenib, DRUG: Venetoclax
Acute Myeloid Leukemia
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
clinicaltrials@northshore.org
ALL
50 years to 105 years old
PHASE3
NCT07136012
Inclusion Criteria:
* Age ≥50 years
* Lp(a)≥ 200 nmol/L during screening
* Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
Exclusion Criteria:
* Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
* Prior or planned arterial revascularization
* History of major bleeding disorder DRUG: Olpasiran, DRUG: Placebo
Cardiovascular Disease
Olpasiran, AMG 890, Coronary heart disease, CHD, Myocardial infarction, Coronary revascularization
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1. (Be6A Lung-02)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT06758401
Inclusion Criteria:
• Participants must meet the following criteria:
• Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition).
• Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.
• Large cell neuroendocrine carcinoma is excluded.
• Candidate for treatment with pembrolizumab monotherapy per local guidelines.
• Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing
• Measurable disease based on RECIST v1.1 per investigator.
• Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.
Exclusion Criteria:
• Life expectancy of \<3 months in the opinion of the investigator.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
• Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
• Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab.
• Participants with any of the following respiratory conditions:
• Evidence of noninfectious or drug-induced ILD or pneumonitis
• Known DLCO (adjusted for hemoglobin) \<50% predicted.
• Grade ≥3 pulmonary disease unrelated to underlying malignancy
• Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \<0.5 cm are permitted.
• Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery within 7 days prior to first dose of study intervention.
• Receipt of a live vaccine within 30 days prior to first dose of study intervention.
• Pre-existing peripheral neuropathy Grade ≥2 per NCI CTCAE v5.0.
• Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7.0% and 8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
• Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, required a high-dose steroid taper (≥0.5 mg/kg prednisone or equivalent per day) for \>2 weeks, or required treatment with systemic immunosuppressive therapy.
• History of autoimmune disease that has required systemic treatment in the past 2 years
• Participants with prior solid organ or bone marrow transplantation.
• Currently receiving a high-dose steroid (\>10 mg prednisone or equivalent per day) or other immune suppressant or has a condition requiring a chronic high-dose steroid or immune suppressant.
• Prior and concomitant therapy:
• Any prior treatment with MMAE-derived drugs or IB6 targeting agents.
• Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC. * (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose. * Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose.
• Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received.
• Chemotherapy, biologics, and/or other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy.
• Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor
• History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV.
• Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months
DRUG: Sigvotatug Vedotin, DRUG: Pembrolizumab
Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC)
Lung Cancer, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer
PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
clinicaltrials@northshore.org
ALL
12 years and over
PHASE2
NCT07355296
Inclusion Criteria:
* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/assent (Visit 1)
* Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
* Weight of ≥40 kg at screening
* Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit
* For adult participants (≥18); ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit
* For adolescent participants (\<18); ≥25 mL/min/1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit
* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \<18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \<18)
* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator
* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)
* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil/-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period
* Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10 mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.
Further inclusion criteria apply.
Exclusion Criteria:
* A history of organ transplantation or planned transplantation during the course of the study
* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit
* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>3X the upper limit of normal (ULN) at screening visit (Visit 1)
* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit
* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply. DRUG: BI 764198, DRUG: Placebo matching BI 764198
Proteinuric Kidney Diseases
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT06701656
Inclusion Criteria:
The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.
* ARDS Severity of mild, moderate or severe, based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization.
Exclusion Criteria:
The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.
* Participant has a known allergy or hypersensitivity to the active substance/excipients, or Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies
* Participant with established cirrhosis and Child-Pugh Score of 7 or greater
* Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \< 2+
* The hospitalized participant has a history or currently experiencing the following:
• Participant must not have an international normalized ratio (INR) \>1.5 and/or aPTT \>1.5 × upper limit of normal (ULN) within 7 days prior to initiation of study treatment for participants not receiving anticoagulation. For participants on full dose oral or parenteral anticoagulants for therapeutic purposes the INR and/or activated partial thromboplastin time (aPTT) must be within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment.
• Participant with recent serious hemorrhage or history of recent hemoptysis \> 2 episodes (defined as ≥2.5 mL of bright red blood per episode) within 1 month of screening.
• Participant with inadequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg). Antihypertensive therapy is permitted to achieve these parameters.
• Participant with a history of hypertensive crisis or hypertensive encephalopathy.
• Participant with a history of Grade ≥ 4 venous thromboembolisms.
• Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.
• Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.
• Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.
• Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).
• Participant with clinically significant cardiovascular disease including cerebrovascular accident or myocardial infarction within previous 6 months, unstable angina, congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication.
• Participant with a platelet count of \<75×109/L.
• Participant with current or recent (\<10 days prior to initiation of study treatment) use of aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day).
• Participant is receiving a direct anticoagulant (DOAC) such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) without the availability of a reversal agent at the site.
• Participant is receiving a DOAC such as betrixaban (Bevyxxa®) and edoxaban (Lixiana®) for which there is no approved reversal agent.
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
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT06701682
Inclusion Criteria:
The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.
* ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
Exclusion Criteria:
* No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073. DRUG: Cohort A: vilobelimab, DRUG: Cohort A: 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
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT06701669
Inclusion Criteria:
The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073:
\- ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization.
Exclusion Criteria:
The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.
-Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80 DRUG: Cohort B: paridiprubart, DRUG: Cohort B: 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
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