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

Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial

Feasibility Research Objectives For the purposes of the pilot phase, the primary objective will be to determine whether it is feasible to conduct a large multi-center RCT that will evaluate the impact of surveillance strategies on patient survival following extremity STS surgery. To do so, we will...

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

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

The purpose of this study is to assess correlations between expression of blood serum biomarkers and cognitive impairment (CI) in patients with colorectal cancer throughout and following chemotherapy treatment. Our primary goal is to establish a panel of biomarkers that predict CI that can be...

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

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

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

A Multi-center, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) plus Pembrolizumab (MK-3475) Versus Placebo plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (6482-022)

Primary To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to...

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 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

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 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

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

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

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- Librexia STROKE Protocol # 70033093STR3001

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

An Open Label Extension Study of Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia

To offer NODE-301, NODE-302 and NODE-303 subjects continued access to Etripamil

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

A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk

Primary Objective: * To evaluate the efficacy of MK-0616 compared with placebo on increasing the time to the first event of death from coronary heart disease, MI, ischemic stroke, acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or...

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 3, Multicenter, Randomized, Open-Label Trial of Epcoritamab in Combination with R-CHOP compared to R-CHOP in Subjects with High-Risk Diffuse Large B-Cell Lymphoma

The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong PFS compared with 6 cycles of standard R-CHOP followed by 2 cycles of rituximab (R-CHOP) in subjects with newly...

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...

Current Studies

ELUCIDATE FFRCT Study

To evaluate the diagnostic accuracy of a plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRCT) software device (ElucidVivoTM) as compared to invasive fractional flow reserve (FFR) in patients who underwent clinically indicated CCTA and invasive FFR.

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)

Current Studies

A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)

Primary Outcome Measures : Time from randomization to treatment failure (TTF) [ Time Frame: Randomization to end of study (up to 39 months after randomization of last patient) ] Time from randomization until platelet count below 30 G/L, need for a rescue treatment or start of a second-line therapy...

Current Studies

NeuroBell

The purpose of the NeuroBell EEG Monitor Clinical Feasibility Study is to evaluate the suitability of the NeuroBell EEG Monitor for use in acquiring neonatal electroencephalogram (EEG)

Current Studies

A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

Primary Outcome Measures : Part 1: To determine the navtemadlin Phase 3 dose [ Time Frame: 12 months ] Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1 Part 2: To compare progression-free (PFS) survival by independent review...

Current Studies

Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)

Primary Outcome Measures: The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene. Secondoary Outcome...