34 Result(s) found
Current Studies
A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing the Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy and Fusion In Patients With Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)
Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at two levels from C3 to C7 that are unresponsive to conservative management.
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A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Ibrutinib or Acalabrutinib in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011) MK1026-PN011
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IlluminOss Device Global Registry a prospective, post-market, multi-center evaluation of the clinical outcomes of the IlluminOss Device.
The primary endpoint of this post market registry study is to provide real-world evidence on the Composite Safety Success rate to enable meaningful comparison to other similar procedures. The Composite Safety Success rate is defined as the absence of Reoperation, Revision, Failure of Fixation,...
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A Two-Arm Randomized, Double-Blind, Placebo-Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With HPV16-Positive, PD-L1-positive, Recurrent or Metastatic Cervical Cancer Who Are Refractory to Pembrolizumab With Chemotherapy With/Without Bevacizumab.
Primary Evaluate anti-tumor efficacy of VB10.16 + placebo and VB10.16 + Atezolizumab Secondary Further evaluate anti-tumor efficacy and response durability of VB10.16 + placebo and VB10.16 + atezolizumab Evaluate clinical efficacy of VB10.16 + placebo and VB10.16 + atezolizumab Characterize safety...
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MK2870-012 Phase III study of MK-2870 Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR
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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...
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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...
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A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)
Primary objective(s) To demonstrate that either dose of ianalumab induces durable hemoglobin (Hb) response compared to placebo, in patients with wAIHA who failed at least one previous line of treatment Secondary objective(s) Key secondary objective: to demonstrate that either dose of ianalumab...
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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
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A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physicians Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy
Primary Objective: To compare MK-2870 to Treatment of Physician s Choice (TPC) with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) To compare MK-2870 to TPC with respect to overall survival (OS) Secondary Objectives: To compare...
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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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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...
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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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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...
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A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)
Primary Outcome Measures : Time from randomization until treatment failure [ Time Frame: Randomization to until end of study (up to 39 months after randomization of last participant) ] Time from randomization until treatment failure is defined as the time from randomization date until the first of...
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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...
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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...
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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...
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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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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
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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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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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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...
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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...
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