Clinical Trials

Current Studies

Effect of Delay in Thrombectomy Reperfusion on Patient Outcome After Acute Ischemic Stroke

This study is aimed at investigating variables in combination recanalization therapies for acute, large vessel ischemic stroke that are associated with better clinical outcomes (measured by NIH stoke scale and modified Rankin Scale). Identification of these variable could potentially improve...

Current Studies

A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)

Primary Outcome Measures: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 5 years ] ORR is defined as the percentage of participants with Complete...

Current Studies

E7181 A Multicenter, Retrospective Series Using a New Injection Capable Electrosurgical Knife for Endoscopic Submucosal Dissection (ESD)

Current Studies

A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia

Primary Outcome Measures Incidence of adverse events following administration of BBP-671 (Time Frame= 43 day) BBP-671 concentration dependent change in change from baseline in QTcF (Time Frame= 43 days) Pharmacokinetic Assessments: Cmax (Time Frame= 43 days) Time to maximum concentration...

Current Studies

Integrated Cancer Repository for Cancer Research (iCaRe2)- Subproject: Pancreatic Cancer Collaborative Registry

OBJECTIVES: Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and treatment of pancreatic cancer by using the power of computer and informatics sciences. Continue development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure to act as a...

Current Studies

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Primary Objectives: To centrally test resected NSCLC for genetic mutations to facilitate accrual to randomized adjuvant studies. To obtain clinically annotated tumor tissue and patient-matched non-malignant DNA from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to...

Current Studies

Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation

Determine if early treatment with dronedarone is superior to usual care for the prevention of cardiovascular hospitalization or death from any cause in patients with first-detected atrial fibrillation.

Current Studies

A Phase 3 Randomized Study of Cystectomy plus Perioperative Pembrolizumab versus Cystectomy Alone in Cisplatin-ineligible Participants with Muscleinvasive Bladder Cancer (KEYNOTE-905)

- Objective: To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab and RC+PLND) and Arm B (RC+PLND), based on central pathologic review, evaluated in participants whose tumors express PD-L1 CPS ≥10 and all participants, irrespective of CPS score. -...

Current Studies

Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions (CLIMB)

Primary Outcome Measures: Accuracy of PCL diagnosis [Time Frame: 48 months] Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types,...

Current Studies

A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer...

Current Studies

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Primary Objectives To compare the complete response rate at 6 cycles after randomization as defined by centrally read PET/CT (integral biomarker) of 2 targeted therapeutic regimens (obinutuzumab + TGR-1202 or obinutuzumab + lenalidomide) with obinutuzumab + CHOP in patients with early relapsing or...

Current Studies

A Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPCA

Primary Objectives Phase II To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of progression-free survival (PFS). Phase III To assess the efficacy of concurrent definitive therapy followed by...

Current Studies

SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Primary Outcome Measures : Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 [ Time Frame: From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to...

Current Studies

EF-36/Keynote B36: A pilot, randomized, open-label study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with pembrolizumab for first line treatment of advanced or metastatic non-small cell lung cancer

Primary Outcome Measures : Objective Response Rate (ORR) [ Time Frame: 24 months ] ORR will be measured from the date of enrollment to date of progression (in months) based on RECIST 1.1 criteria. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50...

Current Studies

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure (ALLEVIATE-HF)

Primary Outcome Measures: *Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events (Time Frame: Up to 3 years) *The proportion of medication interventions with one or more associated medication...

Current Studies

Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO

Primary Objective To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over observation for patients with completely resected stage IB (4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative...

Current Studies

Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68 ( DAPA ACT HF-TIMI 68)

PRIMARY OBJECTIVE To assess the effect of in-hospital initiation of dapagliflozin, as compared with placebo, on the clinical outcomes of cardiovascular death or worsening heart failure in patients who have been stabilized during hospitalization for acute heart failure. To evaluate the safety and...

Current Studies

A Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)

Primary Objective To evaluate the response rate (confirmed, complete or partial) of AMG 510 in participants with KRASG12C mutated Stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). The response rates will be evaluated separately with cohorts defined as: i. Cohort 1 (co-mutation...

Current Studies

A Phase 3 Study of Pembrolizumab (MK-7339) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib Compared with Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

Primary: To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review. To compare...

Current Studies

A Novel Retraction Device for Endoscopic Submucosal Dissection (ESD): A Multicenter Retrospective Study

Specific Study Aims: Study Aim 1: The primary aim of this study was to determine the technical success of ESD using the retraction device by determining completeness of the resection (¬en-bloc vs incomplete). Study Aim 2: We aim to determine the safety of the device with regards to perforation and...

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 Transfemoral Transcatheter Aortic Valve Replacement (COMPLETE TAVR)

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...

Current Studies

EF-32: Pivotal, Randomized, open-label study of Tumor Treating Fields (Optune®, 200kHz) concomitant with radiation therapy and temozolomide for the treatment of newly diagnosed glioblastoma

Current Studies

Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population

Primary An Excision of the targeted lesion in a single specimen Secondary Rate of R0 resection Time Frame 3-4 hours when all vertical and horizontal margins are negative Rate of R1 resection Time Frame 3-4 hours complete resection with no grossly visible lesion defined by...

Current Studies

A Randomized Phase III Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Primary Objective: To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB greater than or equal to 4cm, II and IIIA, ALK-positive NSCLC following surgical resection. Secondary Objectives: To evaluate and compare disease-free...

Current Studies

HPS 4/TIMI 65 ORION 4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease.

The HPS-4/TIMI 65/ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. Consistent with relevant guideline recommendations for people with vascular disease, it is intended that participants be on intensive background LDL-lowering therapy, at screening. The...

Current Studies

Parkview Health Falls Registry

Primary: * To identify risk factors in patient history among patients evaluated at the Fall Prevention Clinic. Secondary: * To compare the characteristics of adult patients who experience falls v/s those who do not. * To review findings on examination (general and neurological) and testing...

Current Studies

A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

Primary Objective of the Master Protocol (LungMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. Secondary Objectives a....

Current Studies

Duodenal endoscopic submucosal dissection, western experience

The purpose of this study is to explore the ESD feasibility and efficacy in duodenal tumors treatment.

Current Studies

A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) when Administered in the Outpatient Setting

Primary The primary objective of this Phase 2 study is to evaluate the safety of Epcoritamab monotherapy without mandatory hospitalization for the first full dose of Epcoritamab in subjects with R/R DLBCL or R/R FL Grade 1-3a who have received at least 2 prior lines of systemic anti-lymphoma...

Current Studies

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

Primary Outcome Measures : Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10 [ Time Frame: Up to approximately 33 months ] PFS is defined as the...

Current Studies

Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip

1) Complete closure rate: proportion of cases in which complete tissue approximation is achieved with the use of the DAT clip (no substantial gaps are visible in the closure line) 2) Achievement of intended targeted therapy: defined as cases in which utilization of the DAT clip accomplished the...

Current Studies

Multicenter Prospective Evaluation of the Efficacy of a Self-Assembling Matrix Forming Gel to Prevent Stricture Formation in High-Risk Patients

Primary Objective/Aim/Goal/Hypothesis Aim. The primary aim is to evaluate the efficacy of the SAP gel in the prevention of stricture formation following endoscopic resection in high-risk patients

Current Studies

Evaluation of the Clinical Outcomes of Peroral Endoscopic Myotomy for the Treatment of Esophageal Dysmotility in Patients on Chronic Opioids

Primary Aim Retrospective analysis of clinical outcomes of POEM for the treatment of symptomatic esophageal dysmotility in patients on chronic opioids. Secondary Aim Factors associated with clinical response to POEM in patients on chronic opioids.

Current Studies

Efficacy of Endoscopic Submucosal Dissection for Previously Attempted Colorectal lesions

To analyze the safety, efficacy and outcomes of endoscopic submucosal dissection (ESD) for previously attempted colorectal lesions in North American population.

Current Studies

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Primary Objective Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with SABR plus placebo vs. SABR plus relugolix. Secondary...

Current Studies

A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barretts Esophagus with Low-grade Dysplasia

3.1 Primary Objective: To compare the effectiveness of two approaches for the management of Barrett s esophagus (BE) and low-grade dysplasia (LGD), endoscopic surveillance and endoscopic eradication therapy (EET), using an accepted clinical endpoint of neoplastic progression [high-grade dysplasia...

Current Studies

Outcomes of Submucosal Tunneling Endoscopic Resection for Subepithelial Tumors in the Upper Gastrointestinal Tract: Experience from the United States

To investigate the safety and efficacy of STER and EFTR for treatment of SELs in the upper GI tract.

Current Studies

RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of...

Current Studies

Evaluation of Outcomes of Advanced Endoscopic Resection and Endoscopic Trans-Mural Drainage Techniques: A Multicenter Study

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...

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...

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...

Current Studies

The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

Primary objective To evaluate and compare the cCR rates in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6. Secondary objective(s) To evaluate and compare organ-preservation-time...

Current Studies

Prospective Observational Study of Clinical Utility of Envisia Genomic Classifier in Patients with Undiagnosed Interstitial Lung Disease

Primary Objective: To evaluate the impact of Envisia on: * Treatment decision: Increase in proportion of patients prescribed anti-fibrotics in those with an Envisia UIP+ result versus their pre-Envisia plan. Secondary Objectives: To evaluate the impact of Envisia on: * Diagnosis: Increase in...

Current Studies

CliNIcal Utility of ManaGement of Patients witH CT and LDCT Identified Pulmonary Nodules UsinG the Percepta NasAL Swab ClassifiEr (NIGHTINGALE) Familiarization and Qualification Protocol

The primary objective is to evaluate whether invasive procedures in the group classified as low-risk by the Percepta Nasal Swab test and that are benign are reduced in the test group who received a Percepta Nasal Swab result as compared to the control group who were managed without a Percepta Nasal...

Current Studies

Endoscopic Stenting in Esophageal Cancer: A Chart Review Study

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

Current Studies

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of HMI-103 Administered Intravenously in Adult Participants with Classical PKU Due to PAH Deficiency.

Primary: Determine the safety of a single administration of HMI-103 To evaluate the efficacy of HMI-103on reduction of plasma Pheconcentration at each dose level

Current Studies

Breast Cancer Collaborative Registry (BCCR)