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273 Study Matches
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)