28 Result(s) found

Current Studies

A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination with Standard of Care Immunotherapy in Participants with Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer -

Part A Primary To compare the efficacy of olomorasib in combination with pembrolizumab versus placebo with pembrolizumab Secondary To compare olomorasib in combination with pembrolizumab versus placebo with pembrolizumab for the following measures: efficacy, changes in HRQoL, safety,...

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Current Studies

A Randomized Study Of LDGraft In Single Level Anterior Lumbar Interbody Fusion (ALIF)

The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).

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Current Studies

20230222: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in High Risk Subjects with Elevated Lipoprotein(a) (AMG 890)

Primary To evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction or urgent coronary revascularization in high-risk participants with elevated Lipoprotein(a) Key Secondary To evaluate the effect of olpasiran, compared...

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Current Studies

OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Primary objective To evaluate whether observation results in a non-inferior RFS compared to adjuvant pembrolizumab in early-stage TNBC patients who achieve a pCR after neoadjuvant chemotherapy with pembrolizumab. Secondary objectives To evaluate whether observation compared to adjuvant...

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Current Studies

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE - RESTORE

Primary Objectives: To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs To determine the factors which are associated with the acute and long-term outcomes of redo TAVR

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Current Studies

Proximal FEmur Reconstruction or Internal Fixation fOR Metastases Randomized Controlled Trial PERFORM

The overall objective of the PERFORM trial is to determine the effect of resection and reconstruction on patient-important outcomes compared to internal fixation for the stabilization of an impending or realized pathologic fracture in patients with metastatic bone disease of the proximal femur. We...

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Current Studies

A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Profici

To compare maintenance treatment with sacituzumab tirumotecan plus pembrolizumab to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed by BICR in participants with pMMR primary advanced or recurrent endometrial cancer To compare maintenance treatment with sacituzumab tirumotecan...

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Current Studies

A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Follow

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab...

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Current Studies

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or

Primary Objective To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with...

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Current Studies

A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum Based Chemotherapy

Primary Objective To determine investigator assessed progression-free survival using RECIST v1.1 (non-inferiority) for one vs. two years of maintenance olaparib. This analysis is supported by a modified ITT population limited to patients on protocol at least 360 days after randomization. The time...

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Current Studies

A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).

Experimental: ISR Corhort Prevail DCB -To evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries. Experimental: DNSV Cohort (RVD 2.0 - 2.75mm) -To evaluate the...

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Current Studies

A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Previously Treated Extensive Stage Small Cell Lung Cancer (ESSCLC)

Primary Objectives To compare the effect of SG to SOC on ORR as assessed by BICR according to the RECIST v1.1 To compare the effect of SG to SOC on OS Secondary Objectives To compare the effect of SG to SOC on PFS as assessed by BICR according to RECIST v1.1 To compare the effect of SG to SOC on...

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Current Studies

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Ce

To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by BICR in all randomised participants.

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Current Studies

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression &#

Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) Part A and Part B: Progression-Free Survival (PFS)

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Current Studies

A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer

Primary: Incidence and proportion of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study ] Selected AEs include xerostomia, xerophtalmia, myelosupression, renal...

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Current Studies

Endoscopic Stenting in Esophageal Cancer: A Chart Review Study

Analyze the outcomes of endoscopic esophageal stent placement in those with esophageal cancer

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Current Studies

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

Primary Objective ctDNA-ve Cohort (Arms 1 + 2): Phase II: To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from...

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Current Studies

The impact of the development of POEM on the frequency of Heller Myotomy procedures in the management of achalasia. A statewide analysis.

Our objective with this study is to take a retrospective look at patients with achalasia in the state of Indiana who have undergone either surgical therapy via laparoscopic or open Heller myotomy, or endoscopic therapy with the Per-oral endoscopic myotomy (POEM) procedure. We plan to compare the...

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Current Studies

Distal Rectal Endoscopic Submucosal Dissection: A Multicenter Retrospective Review

Aim of study: to examine outcomes and complications of rectal ESDs performed within 2 cm of the dentate line Primary endpoints: to determine the rate of R0 resection of rectal ESDs performed within 2 cm of the dentate line Secondary endpoints: to determine complication rates of rectal ESDs...

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Current Studies

(A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective

Primary Objective: To determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the...

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