Search Results
12results
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT02734537
Inclusion Criteria:
* PRE-REGISTRATION (STEP 0)
* Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified \[NOS\]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer \[AJCC\] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0
* Patient has undergone total resection of the primary tumor with curative intent
* NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days
* For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
* Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible
* A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration
* NOTE: Complete the EA3132-specific FoundationOne requisition form
* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor
* Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
* Patients with recurrent disease or multiple primaries are ineligible
* RANDOMIZATION (STEP 1)
* NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion
* Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
* The patient must have the following assessments done =\< 8 weeks prior to randomization:
* Examination by a head and neck surgeon
* Chest x-ray (or chest computed tomography \[CT\] scan or CT/positron emission tomography \[PET\] of the chest or magnetic resonance imaging \[MRI\]) to rule out distant metastatic disease
* Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization
* Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment
* Absolute neutrophil count \>= 1,500/mm\^3 within 4 weeks prior to randomization
* Platelets \>= 100,000/mm\^3 within 4 weeks prior to randomization
* Total bilirubin =\< the upper limit of normal (ULN) within 4 weeks prior to randomization
* Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
* Patient must not have an intercurrent illness likely to interfere with protocol therapy DRUG: Cisplatin, RADIATION: Intensity-Modulated Radiation Therapy, OTHER: Laboratory Biomarker Analysis
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant, Lip and Oral Cavity Squamous Cell Carcinoma, p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oral Cavity Verrucous Carcinoma, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Oral N-acetylcysteine for Retinitis Pigmentosa (NAC Attack)
clinicaltrials@northshore.org
ALL
18 years to 65 years old
PHASE3
NCT05537220
Inclusion Criteria:
General
* Ability and willingness to provide informed consent
* Age ≥ 18 and ≤65 years at time of signing Informed Consent Form
* Ability and willingness to comply with the study protocol and to participate in all study visits and assessments in the investigator's judgement
* For candidates of childbearing potential: willingness to use a method of contraception
* Agreement not to take supplements other than vitamin A
Ocular Inclusion Criteria
* Both eyes must exhibit the RP phenotype with evidence of loss of night vision, gradual constriction of visual fields, and maintenance of visual acuity;
* In addition, an eye must meet the following criteria to be included in the study:
* Gradable EZ on a horizontal SD-OCT scan through the fovea center with width ≤ 8000 µm and ≥1500 µm and with well-defined truncation at both the nasal and temporal sides;
* BCVA ≥ ETDRS letter score of 61 (20/60 Snellen equivalent);
* Sufficiently clear ocular media and adequate pupillary dilation to allow good quality images sufficient for analysis and grading by central reading center.
Exclusion Criteria:
General Exclusion Criteria
* Active cancer within the past 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with Gleason score ≤ 6 and stable prostate specific antigen for \> 12 months
* Renal failure requiring renal transplant, hemodialysis, peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis during the study
* Liver disease, cystic fibrosis, asthma, or chronic obstructive pulmonary disease (COPD), history of thrombocytopenia not due to a reversible cause or other blood dyscrasia
* Uncontrolled blood pressure (defined as systolic \> 180 and/or diastolic \> 100 mmHg while at rest) at screening. If a patient's initial measurement exceeds these values, a second reading may be taken 30 or more minutes later. If the patient's blood pressure must be controlled by antihypertensive medication, the patient may become eligible if medication is taken continuously for at least 30 days.
* History of other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion that oral NAC may be contraindicated or that follow up may be jeopardized
* Cerebrovascular accident or myocardial infarction within 6 months of screening
* Participation in an investigational study that involves treatment with any drug or device within 6 months of screening
* Three relatives already enrolled in study
* Pregnant, breast feeding, or intending to become pregnant during the study treatment period. Women of childbearing potential who have not had tubal ligation must have a urine pregnancy test at screening.
* Known history of allergy to NAC
* Having taken NAC in any form in the past 4 months
* Phenylketonuria
* Fructose intolerance
* Glucose-galactose malabsorption
* Sucrase-isomaltase insufficiency
* Abnormal laboratory value including the value of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin being greater than 1.5 x the upper limit of normal
* Any major abnormal findings on blood chemistry, hematology, and renal function lab tests that in the opinion of the Site Investigator and/or the Study Chair makes the candidate not suitable to participate in the trial
* HIV or hepatitis B infection
Ocular Exclusion Criteria
* Evidence of cone-rod dystrophy or pattern dystrophy including focal areas of atrophy or pigmentary changes in the central macula
* Cystoid spaces involving the fovea substantially reducing vision
* Glaucoma or other optic nerve disease causing visual field loss or reduced visual acuity
* Intra ocular pressure \>27 mm Hg from two measurements. If a patient's initial measurement exceeds 27 mm Hg, a second reading must be taken.
* Any retinal disease other than RP causing reduction in visual field or visual acuity
* Any prior macular laser photocoagulation
* Intraocular surgery within 3 months prior to screening
* High myopia with spherical equivalent refractive error \> 8 diopters. If an eye has had cataract surgery or refractive surgery, a pre-operative refractive error spherical equivalent \> 8 diopters is an exclusion
* Any concurrent ocular condition that might affect interpretation of results
* History of uveitis in either eye DRUG: N-acetylcysteine, DRUG: Placebo
Retinitis Pigmentosa
N-acetylcysteine, Ellipsoid zone, Macular sensitivity, Best corrected visual acuity, Ellipsoid zone width, Ellipsoid zone area, Oxidative damage, Usher Syndrome, Antioxidants
Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Daniel Amusin, BS - damusin@northshore.org
All
18 years and over
Phase 2
NCT04043897
Inclusion Criteria:
• Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsies reviewed by 2 separate pathologists
• CC will be defined histologically to be the following: thickness of the collagenous subepithelial table >10 micrometer using an ocular micrometer, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, lack of crypt architectural distortion, and regenerative-appearing changes in the surface and/or crypt epithelium
• LC will be defined histologically to be the following: intraepithelial lymphocytes >20 per 100 epithelial cells in the subjective area of highest lymphocyte density, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, and regenerative-appearing changes in the surface and/or crypt epithelium
• Subjects in active flare, defined as >3 watery/loose stools per day on >4 / 7 days over >4 weeks in the past 3 months.
Exclusion Criteria:
-
Drug: Rifaximin 550mg
Microscopic Colitis
Microscopic Colitis
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
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (AVENUE)
clinicaltrials@northshore.org
ALL
12 years to 17 years old
PHASE3
NCT07227454
Inclusion Criteria:
* Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)
* Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of "Markedly" or greater (that is, greater than or equal to \[\>=\] 4) at both screening and baseline (predose) visits
* Must have a children's depression rating scale - revised (CDRS-R) total score \>= 58 at baseline (predose)
* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality
* Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Exclusion Criteria:
* Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder
* Participant currently meets DSM-5 criteria for borderline personality disorder
* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis
* Participant has a history of seizure disorder
* Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients DRUG: Esketamine, DRUG: Midazolam, OTHER: Oral Placebo, OTHER: Intranasal Placebo
Depressive Disorder, Major
Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual) (PAUSEVirtual)
clinicaltrials@northshore.org
ALL
18 years to 100 years old
NCT06844227
Inclusion Criteria:
* Age 18 years of age or older with AF/flutter (chronic, persistent, paroxysmal) that requires anticoagulation
* Receiving warfarin, with a target international normalized ratio (INR) range of 2.0-3.0, or a DOAC, comprising one of the following regimens: apixaban, 2.5 mg or 5 mg bid; edoxaban, 30 mg or 60 mg daily; dabigatran, 110 mg or 150 mg bid; or rivaroxaban, 15 mg or 20 mg daily
* Require an elective (planned, non-urgent) surgery or invasive medical or surgical procedure
Exclusion Criteria:
* Indication for anticoagulation is not AF/flutter (e.g., mechanical heart valve, VTE, other)
* Non-standard anticoagulant regimen used (e.g., warfarin INR 3-4, rivaroxaban 2.5 mg bid)
* In DOAC users only: creatinine clearance \<25 mL/min (that preclude DOAC use)
* Cognitive impairment or psychiatric illness (that precludes reliable contact during follow-up)
* Unable or unwilling to provide consent for virtual care (in-person care will be provided)
* Previous participation in this study for an elective surgery/procedure Atrial Fibrillation (AF)
anticoagulation, Atrial Fibrillation, Surgery, Oral Anticoagulant, Blood Thinner, DOAC, Interruption, Perioperative, Virtual, PAUSE
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (RIVER-AD)
clinicaltrials@northshore.org
ALL
12 years and over
PHASE2
NCT05492578
Inclusion Criteria:
* Participant must be at least 12 years of age inclusive at the time of signing the informed consent.
* Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period.
* Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600
* Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:
* The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2.
* The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.
* The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up.
* Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
* Complied with the previous clinical trial protocol to the satisfaction of the investigator
* Body weight must be ≥25 kg
* Provided signed informed assent/or consent and able to comply with the requirements of the protocol Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol
* Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
* History of solid organ or stem cell transplant
* Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)
* Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test
* History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
* Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening
* Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:
• Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
• Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
• For whom review and approval from Sponsor have been granted are eligible * Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease * Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment * Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments * In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
DRUG: Amlitelimab, DRUG: Topical corticosteroids, DRUG: Topical calcineurin inhibitors, DRUG: Oral corticosteroids
Dermatitis Atopic
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
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain (CPMP)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT05986292
Inclusion Criteria:
* have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening.
* have a history of daily pain for at least 12 weeks based on participant report or medical history
* have a value of ≤30 on the pain catastrophizing scale
* have a body mass index \<40 kilogram/square meter (kg/m²) (inclusive)
* are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
* are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study
Exclusion Criteria:
* have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
* have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)
* have surgery planned during the study for any reason, related or not to the disease state under evaluation.
* have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
* have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* have fibromyalgia
* have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
* have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
* have a positive human immunodeficiency virus (HIV) test result at screening
* have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening. DRUG: LY3016859 ISA, DRUG: LY3556050 ISA, DRUG: LY3526318 ISA, DRUG: LY3857210 ISA, DRUG: Placebo Oral, DRUG: Placebo
Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS)
clinicaltrials@northshore.org
ALL
12 years and over
PHASE3
NCT05889182
Inclusion Criteria:
* Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of participant).
* Documented history of previous use of \>= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
* Participant must have a total abscess and inflammatory nodule (AN) count of \>= 5 at Baseline.
* HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
* At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
* Draining fistula count of \<= 20 at Baseline.
Exclusion Criteria:
* History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
* Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
* Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
* Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit. DRUG: Upadacitinib, DRUG: Placebo
Hidradenitis Suppurativa
Hidradenitis Suppurativa, Upadacitinib, ABT-494, Rinvoq, STEP-UP HS
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor (AQUA)
clinicaltrials@northshore.org
ALL
12 years and over
PHASE3
NCT06241118
Inclusion Criteria:
* Participants must be 12 years of age (when signing informed consent form)
* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
* Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
* v-IGA-AD of 3 or 4 at baseline visit
* EASI score of 16 or higher at baseline
* AD involvement of 10% or more of BSA at baseline
* Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
* Able and willing to comply with requested study visits and procedures
* Body weight ≥25 kg
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Skin co-morbidity that would adversely affect the ability to undertake AD assessments
* Known history of or suspected significant current immunosuppression
* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline)
* History of solid organ or stem cell transplant
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial DRUG: Amlitelimab, DRUG: Placebo, DRUG: Topical corticosteroids, DRUG: Topical tacrolimus or pimecrolimus
Dermatitis Atopic
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
clinicaltrials@northshore.org
ALL
40 years to 75 years old
NCT05334069
Inclusion Criteria:
* Participants with a cancer diagnosis: Documentation of disease:
* Histologic documentation: Histologically confirmed diagnosis of invasive cancer
* Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma
* For leukemia: Type (chronic lymphocytic leukemia \[CLL\], chronic myeloid leukemia \[CML\], acute lymphoblastic lymphoma \[ALL\], acute myeloid leukemia \[AML\])
* For lymphoma: Stage I-IV based on Ann Arbor staging
* For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)
* One of the following tumor types:
* Colorectal
* Bladder
* Head and neck
* Hepatobiliary
* Lung
* Lymphoma
* Leukemia
* Ovary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Pancreas \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Multiple myeloma
* Gastric, esophageal or gastroesophageal
* Breast
* Thyroid
* Kidney
* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Endometrium
* Prostate
* Melanoma
\*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Sarcoma
* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention
* Participants with a cancer diagnosis: Age \>= 40 and =\< 75
* Participants with a cancer diagnosis: No known current pregnancy by self-report
* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
* Participants with a cancer diagnosis: Willingness to provide blood samples for research use
* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL
* Participants with a cancer diagnosis: No history of organ transplantation
* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish
\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
* Participants without a cancer diagnosis and without suspicion of cancer: Age \>= 40 and =\< 75
* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report
* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use
* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation
* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish
\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw
\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma
* Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs
* Participants with a high suspicion of cancer: Age \>= 40 and =\< 75
* Participants with a high suspicion of cancer: No known current pregnancy by self-report
* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use
* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
* Participants with a high suspicion of cancer: No history or organ transplantation
* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages OTHER: Questionnaire Administration, PROCEDURE: Biospecimen Collection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Ann Arbor Stage I Lymphoma, Ann Arbor Stage II Lymphoma, Ann Arbor Stage III Lymphoma, Ann Arbor Stage IV Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Gastroesophageal Junction Adenocarcinoma, Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Invasive Breast Carcinoma, Kidney Carcinoma, Malignant Hepatobiliary Neoplasm, Malignant Solid Neoplasm, Melanoma, Muscle-Invasive Bladder Carcinoma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma, RISS Stage III Plasma Cell Myeloma, Sarcoma, Stage I Bladder Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage I Colorectal Cancer AJCC v6 and v7, Stage I Esophageal Cancer AJCC V7, Stage I Gastric Cancer AJCC V7, Stage I Lung Cancer AJCC v7, Stage I Ovarian Cancer AJCC v6 and v7, Stage I Pancreatic Cancer AJCC v6 and v7, Stage I Prostate Cancer AJCC v7, Stage I Uterine Corpus Cancer AJCC v7, Stage II Bladder Cancer AJCC v6 and v7, Stage II Breast Cancer AJCC v6 and v7, Stage II Colorectal Cancer AJCC v7, Stage II Esophageal Cancer AJCC v7, Stage II Gastric Cancer AJCC v7, Stage II Lung Cancer AJCC v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage II Pancreatic Cancer AJCC v6 and v7, Stage II Prostate Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage III Bladder Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage III Colorectal Cancer AJCC v7, Stage III Esophageal Cancer AJCC v7, Stage III Gastric Cancer AJCC v7, Stage III Lung Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Pancreatic Cancer AJCC v6 and v7, Stage III Prostate Cancer AJCC v7, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Bladder Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Colorectal Cancer AJCC v7, Stage IV Esophageal Cancer AJCC v7, Stage IV Gastric Cancer AJCC v7, Stage IV Lung Cancer AJCC v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Pancreatic Cancer AJCC v6 and v7, Stage IV Prostate Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7, Thyroid Gland Carcinoma