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A Phase 1 Study of the Safety and Tolerability of CTX-10726
Jeff Edenfield, MD - jeffery.edenfield@prismahealth.org
ALL
18 years and over
PHASE1
NCT07419841
Inclusion Criteria:
• Age 18 years or older.
• Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including: 2a: Renal Cell Carcinoma (RCC) * Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means. * Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PDL1) treatment. * Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI). * Patients who received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose or received major surgical treatment within 3 weeks before the first dose are not eligible. 2b: Hepatocellular Carcinoma (HCC) * Patients who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment. * Patient must have received one of the following regimens: ipilimumab+nivolumab, tremelimumab+durvalumab, atezolizumab+bevacizumab or lenvatinib+pembrolizumab. * Hepatic function: Child -Pugh A and Child-Pugh B7. * Receipt of local area treatment of the liver more than 4 weeks prior to the first dose is allowed. 2c. Gastroesophageal Cancer (GC) * Patients who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment. * Patients must have received prior treatment with platinum-based chemotherapy. 2d: Endometrial Cancer (EC) * Patients must have received at least 1 cycle of platinum-based chemotherapy. * Patients with newly diagnosed advanced endometrial cancer that have persistent lesion(s) after standard treatment with surgery and chemotherapy ± radiotherapy. * Patients with MSI- high or deficient DNA mismatch repair (dMMR) tumors who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment. 3\. Patients must have measurable disease per RECIST 1.1. Tumor sites that are considered measurable must not have received prior radiation. 4\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5\. Adequate organ function including: * Bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion). * Hepatic function defined as serum total bilirubin ≤ 1.5 × ULN (\<3 x ULN in patients with Gilbert's syndrome), AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases). * Renal function defined as creatinine clearance ≥ 30 mL/min by Cockcroft Gault equation. * Cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%. 6\. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment. 7\. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-10726. 8\. Prior anticancer therapy \> 28 days (or 2 half-lives for proteins, whichever is shorter), radiotherapy \> 7 days (concurrent localized palliative radiotherapy is allowed during CTX-10726 treatment with medical monitor approval), therapeutic surgical intervention \> 21 days, blood transfusion \> 14 days, or biopsy or minor surgery (excluding placement of vascular access devices) \> 7 days prior to the first dose of CTX-10726. 9\. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2 (excluding alopecia). 10\. Capable of understanding and complying with protocol requirements 11\. Signed and dated institutional review board (IRB) approved informed consent form (ICF) before any protocol-directed screening procedures are performed.
Exclusion Criteria:
• Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to discontinuation of treatment. A prior irAE may be considered not exclusionary only after consultation with the Medical Monitor if it resolved or stabilized to Grade 1 or baseline before informed consent, has been clinically stable for at least 3 months, and does not require ongoing systemic corticosteroids or other systemic immunosuppressive therapy other than protocol-permitted physiologic replacement. Participants are not eligible if the prior irAE was severe or life-threatening, involved a high-risk organ system with potentially dangerous recurrence, was recurrent or occurred after rechallenge, required second-line immunosuppressive therapy beyond corticosteroids, suggested broad immune susceptibility, or could confound safety evaluation in this first-in-human study.
• Prior organ transplantation.
• History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.
• History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.
• Symptomatic or uncontrolled central nervous system (CNS) and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for \>4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.
• A pleural, abdominal (eg, ascites) or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc) within 14 days of dosing with CTX-10726.
• Imaging at screening that shows the tumor surrounds important blood vessels or had obvious necrosis and voids, and the investigators deems that it might cause bleeding risk.
• The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.
• A history of significant bleeding tendency or severe coagulopathy.
• Current therapeutic dose of anticoagulant or thrombolytic medication within 14 days of the first dose. Note: prophylactic use of low molecular heparin (ie, enoxaparin 40 mg/day) is allowed.
• Current or recent use of aspirin (\> 325 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days of first dose.
• Known uncontrolled diabetes mellitus despite optimized anti-diabetes medications.
• The presence of poorly controlled hypertension (systolic blood pressure \[SBP\]/diastolic blood pressure \[DBP\]) \>140/90 mmHg (eg, patient with SBP/DBP \> 140/90 mmHg despite ≥3 anti-hypertensive medications within 7 days of dosing with CTX-10726).
• Pregnant or lactating WOCBP.
• Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.
• Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be \< 1000 copies /ml (200 IU/ml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug treatment. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required.
• HIV-infected subjects who meet the following criteria are eligible for inclusion: HIV-RNA levels below the lower limit of detection.
• Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection).
• Patients that received attenuated vaccination within 4 weeks prior to screening or planning to receive attenuated vaccination during the study period.
• Current or recent systemic therapy with immunosuppressive agents within 7 days before the start of CTX-10726 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement (≤ 10 mg/day prednisone or equivalent) for patients with adrenal insufficiency are allowed.
• Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \> 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor.
• Active or prior documented idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except localized interstitial pneumonia due to radiotherapy induction), pulmonary fibrosis, severe respiratory distress, pulmonary insufficiency or continuous oxygenation.
• Other medical conditions in the opinion of the Investigator and/or Sponsor Medical Monitor may interfere with the conduct and/or interpretation of the current study, including:
• Congestive heart failure (\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias.
• QTc interval (using Fridericia correction calculation) \> 480 msec.
DRUG: CTX-10726
Gastroesophageal Cancer (GC), Hepatocellular Carcinoma (HCC), Endometrial Cancer, Renal Cell Carcinoma (RCC)
Serranator POINT FORCE Registry (POINT FORCE)
Nikita Kasinger - nikita.kasinger@prismahealth.org
ALL
18 years and over
NCT06687590
Inclusion Criteria:
* Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
* Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
* Age of subject is \> 18.
* Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.
Exclusion Criteria:
* Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
* Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints. DEVICE: Peripheral balloon angioplasty
Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft
Effects of E-Cigarette Flavors on Adult E-Cigarette Users With Opioid Use Disorder (FLAVOR)
Alain Litwin, MD - alain.litwin@prismahealth.org
ALL
21 years and over
NCT07594717
Inclusion Criteria:
* Adults aged 21 years or older.
* Current e-cigarette users who report e-cigarette use on ≥20 of the past 30 days.
* Former daily cigarette smokers who currently smoke on ≤19 days per month and no more than 5 cigarettes per day.
* Diagnosed with opioid use disorder (OUD).
* Currently receiving buprenorphine treatment for OUD.
Exclusion Criteria:
\- DRUG: Sweet-cooling, DRUG: Sweet non-cooling EC flavor, DRUG: Tobacco flavor EC
Nicotine Use Disoder, Opioid Use Disorder
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Kim Williams - Kim.Williams3@Prismahealth.org
ALL
18 years and over
PHASE2
NCT07326566
Key
Inclusion Criteria:
* Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).
* Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).
* For Part 1 (Safety Lead-in) ONLY: EGFR alterations.
* For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.
* For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.
* No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.
* At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.
Key Exclusion Criteria:
* Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.
* Progression of GBM prior to Enrollment, Screening, or Randomization.
* Biopsy-only/no resectional surgery.
* Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.
* Intent to use Optune® (TTF).
* Significant other uncontrolled health conditions or other malignancies. DRUG: silevertinib in combination with temozolomide, DRUG: temozolomide (TMZ)
Glioblastoma (GBM), Newly Diagnosed Glioblastoma, GBM, Glioblastoma Multiforme (GBM), Glioma, Central Nervous System Diseases, Brain Cancer
EGFR, Glioblastoma, Unmethylated, Unmethylated MGMT promoter, Newly Diagnosed, temozolomide, Temodar, silevertinib, BDTX-1535, EGFR alterations, epidermal growth factor receptor, EGFRvIII, epidermal growth factor receptor (EGFR)
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
ALL
18 years to 80 years old
PHASE2
NCT07226791
Inclusion Criteria:
\- Midline ventral hernia requiring open surgical repair.
Exclusion Criteria:
* Medical condition that may put the participant at increased risk with exposure to AGN-151607-DP, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function.
* History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening. DRUG: AGN-151607-DP, DRUG: Placebo for AGN-151607-DP
Ventral Hernia
Ventral Hernia, AGN-151607-DP, Primary fascial closure, Open Abdominal Ventral Hernia Repair
A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms
Dr Bhumika Patel - Bhumika.Patel@prismahealth.org
ALL
18 years and over
PHASE1
NCT07629726
Inclusion Criteria:
* Participants must be at least 18 years of age at the time of signing the informed consent.
* At least 1 measurable diseases based on CT scan or MRI
* Renal function values
* Participants who have an ECOG PS score of 0, 1 or 2.
* Be willing to provide a fresh tissue taken at current relapse at screening period.
* Meet laboratory values at Screening i.e., ANC, Platelets, Corrected serum calcium, AST and ALT, Total bilirubin etc
* Contraceptive use by \[men and women\] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Women of childbearing potential and fertile men must agree to use highly effective contraceptive methods • At least 1 measurable diseases based on CT scan or MRI
* Capable of giving signed informed consent
* Health Information Access: Capable of providing access to personal health information via HIPAA authorization (US only).
* Legal Status: Not under any administrative or legal supervision or institutionalization due to regulatory or juridical order.
Exclusion Criteria:
* Medical Conditions
* History of prior allogenic transplant.
* Presence of Grade 2 peripheral neuropathy with pain.
* Impaired cardiac function or clinically significant cardiac disease at Screening
* Known active CNS involvement or clinical signs of meningeal involvement.
* Evidence of HIV infection.
* Active chronic HBV/HCV infection,
* Participants with positive anti-HBc must have a negative HBV-DNA quantification test result to be enrolled.
* Receipt of any anti-tumor therapy within three weeks or at least five half-lives prior to the Screening visit, whichever is shorter.
* Toxicities from prior anticancer therapies that have not resolved to Grade 1 or less except for abnormal clinical values alopecia and peripheral neuropathy (participants with Grade 1 or 2 neuropathy without pain are eligible for enrollment).
* Use of systemic corticosteroids exceeding 10 mg/day of prednisone or equivalent within 14 days prior to the first dose DRUG: KK2430
Hematologic Neoplasms
EVERO Drug-coated Balloon (DCB) Randomized Trial
Noah Shields - noah.shields@cookmedical.com
ALL
18 years and over
NA
NCT07144150
Inclusion Criteria:
• Documented PAD with Rutherford classification 2 - 4; and
• De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.
Exclusion Criteria:
General Exclusion Criteria
• Less than 18 years old;
• Inability or refusal to give informed consent by the patient or legally authorized representative;
• Life expectancy ≤ 12 months, per investigator assessment;
• Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;
• Unable or unwilling to comply with the follow-up schedule; or
• Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.
COMBINATION_PRODUCT: Evero DCB, COMBINATION_PRODUCT: Paclitaxel DCB
Peripheral Vascular Disease, Peripheral Arterial Disease
Intermittent claudication, Paclitaxel, Everolimus, Rapamycin, Drug-coated balloon (DCB), Percutaneous transluminal angioplasty (PTA), Femoropopliteal artery, Superficial femoral artery (SFA), Popliteal artery
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) (SUPPORT II)
Vince Vismara, M.D. - Suzanne.Smith@PrismaHealth.org
ALL
18 years to 90 years old
NA
NCT07296744
Inclusion Criteria:
* Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team
* Informed consent granted by the subject or legally authorized representative
Exclusion Criteria:
* Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
* Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
* Left ventricular thrombus
* Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
* Ongoing renal replacement therapy with dialysis
* Presence of decompensated liver disease; severe liver dysfunction
* Infection of the proposed procedural access site or active infection
* Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol
* Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
* Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
* Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure
* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures
* Considered to be part of a vulnerable population per the investigator's assessment DEVICE: The Supira System, DEVICE: Impella
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
Percutaneous ventricular assist device, Supira System, Mechanical Circulatory Support, US Pivotal
Phentermine's Impact on Treatment in Teens (PhITT)
Page Wiggins - mollie.wiggins@prismahealth.org
ALL
12 years to 17 years old
PHASE2
NCT07282340
Inclusion criteria\* include, but are not limited to:
* Age ≥ 12 years and \< 18 years at time of consent;
* Tanner Staging ≥ 2 at the time of screening;
* Obesity (BMI ≥ 95th age- and sex-specific CDC percentile or BMI ≥ 30 kg/m2);
* Biological females must agree to use adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.
Exclusion criteria\* include, but are not limited to:
* Contraindications to phentermine in adults such as:
* A history of cardiovascular disease (e.g., coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, and congestive heart failure);
* History of glaucoma;
* Current or recent (within 14 days of screening) use of a monoamine oxidase (MAO) inhibitor;
* Any previous history of drug dependency or current use of an illicit substance (positive urine drug screen);
* Current pregnancy or breastfeeding;
* Plans to become pregnant within the study duration;
* Known hypersensitivity to sympathomimetic amines;
* Current nicotine use or nicotine cessation within 3 months of screening;
* Stage 2 hypertension (or greater) or taking any medication to treat hypertension;
* Current type 1 or type 2 diabetes mellitus or taking any medication to treat diabetes or prediabetes;
* Current or recent (within 3 months of screening) use of prescribed weight loss medication(s)/medically prescribed diets (e.g., low calorie, meal replacement/herbal agents/dietary supplements or weight loss program);
* Current or recent (within 3 months of screening) use of other sympathomimetic amines such as stimulants to treat attention- deficit/hyperactive disorder;
* Use of chronic systemic glucocorticoid therapy (consecutive use of 3 months or more) or other steroid hormone therapy other than oral contraceptives;
* Use of tricyclic antidepressants, lithium, levodopa, or dopamine receptor agonists;
* History of bariatric surgery;
* History or current diagnosis of schizophrenia, psychosis, bipolar disorder, or mental illness requiring hospitalization within 12 months of screening;
* History of suicide attempt within 2 years or self-harm within 3 months of screening;
* Current Patient Health Questionnaire-9 (PHQ-9) score of ≥ 10;
* Current suicidal ideation type 4 or 5 on Columbia Suicide Severity Rating Scale (C-SSRS);
* Current Eating Attitudes Test-26 (EAT-26) score ≥ 20 or any history of anorexia or bulimia.
* Current condition or disease interfering with metabolism, such as untreated hypo- or hyperthyroidism, Cushing's syndrome;
* Current clinically significant hepatic aspartate transaminase (AST) or alanine transaminase (ALT) \> 3x upper limit of age- and sex-specific normal range or renal disease (creatinine clearance \< 60 mL/minute); hypertriglyceridemia (triglyceride ≥ 400 mg/dL) or syndromic or monogenic obesity;
* Any clinically significant abnormalities on a standard 12-lead electrocardiogram at baseline;
* Heart rate \> 100 bpm at screening;
* Current or recent use of any investigational medication or device or participation in an interventional clinical trial within 30 days of screening;
* Any clinically significant medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation, investigational product administration, or interpretation of trial results.
DRUG: Phentermine, DRUG: Placebo
Childhood Obesity
Adolescent Obesity, Pediatric Obesity, Weight Loss, BMI Reduction, Phentermine
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
Shawn Manos - shawn.manos@prismahealth.org
ALL
22 years and over
NCT06604884
Inclusion Criteria:
• Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law.
• Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.
• Patient is an adult per local law at time of consent.
Exclusion Criteria:
• Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.
• Patient who may be unable to complete the study follow-up.
• The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
• Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
• Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
DEVICE: Treatment of Intracranial Aneurysms
Intracranial Aneurysm
The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease (LIBRA)
Trial Transparency email recommended (Toll free for US & Canada) - contact-us@sanofi.com
ALL
10 years to 65 years old
PHASE3
NCT06975865
Inclusion Criteria:
* Participants who have been diagnosed with SCD.
* Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.
* Participants who are either not on hydroxyurea and/or L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and/or L-glutamine for a minimum of 6 months. Participants on hydroxyurea and/or L-glutamine must have been on a stable weight-based dose level (mg/kg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons.
* Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* For participants ≥10 to \<18 years of age: the parent(s)/legal guardian(s) must provide written informed consent prior to any study-related procedures being performed.
Exclusion Criteria:
* Participants are excluded from the study if any of the following criteria apply: Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.
* Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings.
* Participants with history of stroke, or history of abnormal transcranial doppler.
* Participants with uncontrolled or active HBV infection and/or HCV infection including those receiving antiviral therapy at the time of screening.
* HIV infection.
* A history of active or latent tuberculosis (TB)
* Positive COVID-19 molecular test.
* Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and/or voxelotor (OXBRYTA®) within 30 days prior to the Screening visit.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. DRUG: Rilzabrutinib, DRUG: Placebo
Sickle Cell Disease
MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP) (FASTER-HIP)
Kyle Jeray, MD - kyle.jeray@prismahealth.org
ALL
60 years and over
NA
NCT07244211
Inclusion Criteria:
* 60 years of age or older undergoing surgery due to a minimally displaced femoral neck fracture
* The patient has a health condition affecting physical mobility.
* Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging.
* Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation without reduction.
* Low energy injury mechanism.
* Surgeons with expertise in internal fixation and total hip arthroplasty or hemiarthroplasty are available to perform surgery.
Exclusion Criteria:
* The patient is not clinically suitable for either compared treatment.
* Expected injury survival of less than 12 months.
* Terminal illness with expected survival of less than 12 months.
* Incarceration.
* Unable to obtain informed consent due to language barriers.
* Unable to obtain informed consent because the legally authorized representative was unavailable.
* Problems, in the judgment of the study personnel, with maintaining follow-up with the patient.
* Currently enrolled in a study or intervention domain that does not permit co-enrollment.
* Prior enrollment in the specific platform trial intervention domain.
* Patient or legally authorized representative did not provide informed consent (declined participation).
* Eligible patient or legally authorized representative was not approached within the screening window (missed participant).
* Other reasons to exclude the patient, as approved by the data coordinating center.
* Associated lower extremity injury that prevents post-operative weight-bearing.
* Retained hardware around the hip that precludes either study treatment.
* Infection around the hip (soft tissue or bone).
* Pathologic fracture with a lytic lesion in the femoral neck that precludes internal fixation.
* Injury did not occur within 21 days of screening.
* Patient is too ill, in the judgment of the attending surgeon, for internal fixation.
* Patient is too ill, in the judgment of the attending surgeon, for arthroplasty. PROCEDURE: Hip arthroplasty, PROCEDURE: Internal fixation
Femoral Neck Fractures
Minimally displaced femoral neck fractures, arthroplasty, hip fractures, femoral fractures, orthopaedic procedures, older adults, patient-centered outcomes, adaptive trial, internal fixation, pragmatic trial